MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-12-22 for DEROYAL 1117PP manufactured by Deroyal Industries, Inc..
[63090305]
Reference mdrs 3006851902-2016-00012, 3006851902-2016-00013. Investigation findings: actual complaint sample(s) were not sent back. However, samples from same lot were available for review and were received by deroyal. Members of the investigation team attempted to reproduce the reported breaks. However, when handled as directed, investigators were unable to induce a break at the white chin bridge. This is consistent with previous results from use testing. In may of 2015, deroyal noticed complaints that reported the emt select extraction collars breaking at the plastic piece under the chin. This piece is molded and made from polypropylene resin. It is called the adult front body, part number ppf0302c.. As a result, a capa investigation was immediately initiated ((b)(4)). At the time investigators were unable to induce a break when collar is handled as intended. Finally, experiments were run to find the root cause of the reported breaks. If a plastic piece were to break easily, it would be due to brittleness. A brittle plastic piece could lead to a break at the chin bridge. Two potential causes of brittleness are color load and molding temperature. It is possible that too high a color load could result in brittleness of the polypropylene (pp) materials in question. It is also possible that if the cooling rate of mold is too fast, then this could possibly result in brittleness. There are manufacturing specification ranges for both of these parameters. In an attempt to induce the malfunction, the team investigated the effect of variation two key molding parameters (molding temperature and color loading) on the corresponding plastic piece. Pp white molded pieces were molded at different color loads and molding temperature that represented the best case, worse case and midpoint scenarios. The resulting molded parts were manually and mechanically tested. No statistically significant difference found by either test for any of the molding conditions tested. After being unable to reproduce the reported failure by either experiment or manual handling of the collars, it was concluded that user error is the likely root cause. The end user applying the collars were not handling the product as intended. When applied as directed, investigators were unable to induce malfunction. However, malfunction could eventually be induced if the collar was bent or rolled tightly enough. This type of handling is not consistent with the instructions. One of our engineering investigators proposed that changing the pp resin used in molded part may lead to increase strength of the molded part. This in turn may make up for when the collar is not handled as intended. Test results (eng. Pcl. 001 protocol and summary report) showed that molded parts using the proposed resin (10-6114) resulted in increased strength. An engineering change order was submitted and approved to change the polypropylene (pp) resin raw material. The first lot of this product that incorporated molded pieces with this new polypropylene resin was manufactured on 01/27/2016 (lot 41545015). As of december 20, 2016, only one complaint ((b)(4)) has come in for collars manufactured after this date. That complaint ((b)(4)) reported that the collars were received broken in package. Review of work order for the current complaint ((b)(4), lot 39556129) showed that it was manufactured before the change in polypropylene resin raw material was implemented. Health risk assessment: as part of our investigation, a health risk assessment (hra) was performed, in november 2015, to see if a product recall was necessary (attachment 1). The team that took part in the analysis had representatives from the following departments: regulatory, quality assurance, engineering r & d, marketing and manufacturing (engineering, molding and tooling). Investigators concluded that user error is the likely root cause. The user not handling the collar as intended. When applied as directed, investigators were unable to induce malfunction. However, malfunction could eventually be induced if the collar was bent or rolled tightly enough. This type of handling is not consistent with the instructions. In the analysis, it was determined that if a device were to malfunction, it is unlikely to result in injury. If an injury were to occur it would most likely be either (a) temporary or reversible (without medical intervention) or (b) limited (transient, minor impairment or complaints). Consistent with this conclusion is that none of the complaints have reported a patient injury. The estimated rate of unit reported per units sold was calculated to be (b)(4). This was calculated by dividing the total number of units reported to break by the total number of units sold. Taking into account the recent information, this estimate is still valid. Between, january 1, 2015 and january 29, 2016, there have been a total of 32 collars reported to be malfunctioning and (b)(4) units sold. This results in an estimated rate of (b)(4) of malfunctioning units reported per unit sold. Based on the health risk assessment performed for this product, that the malfunctioning rate has not changed, that this product is ordered by and sold to customers quickly, and that the new modified product has started to be shipped out to customers, it is our opinion that no action is required at this time with respect to removing this product from commercial use or distribution. Root cause: investigators originally concluded that user error is the likely root cause. The user not handling the collar as intended. When applied as directed, investigators were unable to induce malfunction. However, malfunction could eventually be induced if the collar was bent or rolled tightly enough. This type of handling is not consistent with the instructions. This lot was manufactured before the change in polypropylene resin raw material was implemented. Correction: customer returned all remaining/unused product from the same lot as complaint sample. Corrective action an engineering change order was submitted and approved to change the polypropylene (pp) resin raw material. The first lot of this product that incorporated molded pieces with this new polypropylene resin was manufactured on 01/27/2016 (lot 41545015). As of december 20, 2016, only one complaint ((b)(4)) has come in for collars manufactured after this date. That complaint ((b)(4)) reported that the collars were received broken in package. Preventive action: a preventive action is not needed at this time. As the new lots of our modified emt select extrication collars go out into the market, deroyal will continue to monitor trends for these failure types and will recognize if it becomes a recurring issue. No further information is available at this time. We will provide follow up report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[63090306]
Date of occurrence: (b)(6) 2016. When did quality issue occur? Before use. Who was using or operating the product when the quality issue occurred? Health professional. Detailed description of quality issue: clinical team noticed the plastic in the front of the collar cracking/breaking. How was the quality issue was identified? By visual inspection. How was the product being used? As intended. Was it the initial use of the product? No. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: no report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2016-00011 |
| MDR Report Key | 6197886 |
| Report Source | USER FACILITY |
| Date Received | 2016-12-22 |
| Date of Report | 2016-11-02 |
| Date of Event | 2016-11-02 |
| Date Mfgr Received | 2016-11-02 |
| Date Added to Maude | 2016-12-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ELIZABETH REED |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621256 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | KM7 AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BUILDING 18 |
| Manufacturer City | SANTIAGO, DOMINICAN REPUBLIC |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | CERVICAL COLLAR |
| Product Code | IQK |
| Date Received | 2016-12-22 |
| Model Number | 1117PP |
| Lot Number | 39556129 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | KM7 AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BUILDING 18 SANTIAGO, DOMINICAN REPUBLIC DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-22 |