MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-29 for NECK ORTHOSIS 14-103A-00 manufactured by Deroyal Industries, Inc..
[71233142]
The complaint call states that the "collar cracked under chin. " the complaint call did not specify if the collar was broken during application on a patient. The issue was reported as being identified before actual use of the product. The sample was received by qc manager based on picture attached to the call, collar was indeed cracked under chin. Device history record (dhr) of the work order (b)(4) provided with the call and work order subassembly and the set up sheets, were reviewed no discrepancies could be found. This part is molded from polypropylene (pp) resin. Qc manager in conjunction with molding supervisor and molding technician evaluated the pictures attached to the call. While evaluating the section where the cracked occurred, from molding supervisor perspective, this area could be improve by reinforcing it and adding more plastic, this will give more strength and robustness to this area. Ppf0302c molding will be sent to the responsible personnel to make the necessary improvements. A corrective and preventive action report (corp (b)(4)) investigation was performed for similar complaints in 2015. As a result, the polypropylene (pp) resin raw material was changed to improve the elasticity of this part. The first lot of this product that incorporated molded pieces with this new polypropylene resin was manufactured on 01/27/2016 (lot 41545015). It was confirmed that the work order provided within the call was manufactured after the improvement. Although the breakages are occurring, the amounts of complaints received due to this condition have been reduced. As of 03/22/2017, only 4 complaints that call for this type of failure has been received, for product manufactured after the previous corrective action, was implemented. Although, at this time, a definitive root cause could not be determined after examining all available information (finished good work order, sub-assembly and molding set up sheet). With the conclusion about the meeting held with molding supervisor and his inputs about the cracking issue, a potential root cause could be based on piece design and his experience, this section could allow a weakness that may lead to the whole middle section cracking. As corrective action another improvement will be made to the mold by adding more plastic to the middle section. This will give more strength and robustness to this area. The planned completion dates for this improvement, to be made to the mold, is set to the 16/jun/2017. Between, january 1, 2015 - march 27, 2017, there have been a total of 7 collars reported to be malfunctioning and (b)(4) units sold, of this product 14-103a-00 neck orthosis, semi-rigid. No further information is available at this time. We will provide a follow up report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[71233143]
*** quality issue details *** date of occurrence: (b)(6) 2017. When did quality issue occur? Before use. Who was using or operating the product when the quality issue occurred? Not applicable. Was a medical procedure involved? No. Name of medical procedure: not applicable. Did the quality issue cause a delay in the medical procedure? Not applicable. Detailed description of quality issue: collar cracked under chin. How was the quality issue was identified? By visual inspection. How was the product being used? Spinal precaution. Was it the initial use of the product? Yes. Was the product modified from the original condition supplied by deroyal? No. Was the product connected to or used in conjunction with other devices or equipment? No. *** outcome details *** outcome(s) attributed to quality issue: none. Person(s) affected by outcome(s) checked above: none. Known pre-existing condition(s) of person(s) affected: none specified. Was the incident reported to the fda? No. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: none.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2017-00008 |
| MDR Report Key | 6443037 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-29 |
| Date of Report | 2017-02-27 |
| Date of Event | 2017-02-27 |
| Date Mfgr Received | 2017-02-27 |
| Date Added to Maude | 2017-03-29 |
| 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. MELISSA LOGSDON |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626157 |
| Manufacturer G1 | DEROYAL INTERCONTINENTAL , S.R.L |
| Manufacturer Street | KM 7, AUTOPISTA JOAQUIN BALAGUER, PISANO FREE ZONE, 18 |
| Manufacturer City | SANTIAGO, |
| Manufacturer Country | DR |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NECK ORTHOSIS |
| Generic Name | ORTHOSIS, CERVICAL |
| Product Code | IQK |
| Date Received | 2017-03-29 |
| Returned To Mfg | 2017-03-08 |
| Model Number | 14-103A-00 |
| Lot Number | 42667495 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-29 |