MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-09-06 for DEROYAL 14-103A-00 manufactured by Deroyal Intercontinental , S.r.l.
[85636244]
The complaint call states that the "anterior panel has broken in a spot below chin piece. " 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 broken in a spot below the chin piece. Device history record (dhr) of the work order (b)(4) provided with the call was reviewed no discrepancies were found. 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. (b)(4) molding will be sent to the responsible personnel to make the necessary improvements. A corrective and preventive action report ((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. Although, at this time, a definitive root cause could not be determined after examining all available information, a potential root cause could be that the section could allow a weakness that may lead to the whole middle section cracking. As corrective action another improvement was made to the mold by adding more plastic to the middle section. This will give more strength and robustness to this area. The improvement was made 06/2/2017 to the area around the rivet hole. It was thickened in that area and support ribs where added. Engineering change order (b)(4) will be initiated to document the improvements made to the mold. Qc manager in conjunction with operations manager, molding supervisor, molding technician and production manager evaluated (b)(4) pieces processed with the new mold by completely assembly them and it was concluded that the pieces were stronger. The first work order for the raw material been produced with the improved mold is (b)(4). Between, (b)(6) 2015 - (b)(6) 2017, there have been a total of (b)(4) collars reported to be malfunctioning for a percentage of (b)(4) units sold, of this product (b)(4) neck orthosis, semi-rigid. The investigation is complete at this time. We will provide a follow up report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[85636245]
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: the anterior panel has broken in a spot just below where the chin piece. How was the quality issue was identified? By visual inspection. How was the product being used? The product was identified as broken before use. 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: the product was never put on the patient because it was identified as broken beforehand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2017-00012 |
| MDR Report Key | 6844281 |
| Report Source | USER FACILITY |
| Date Received | 2017-09-06 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-08-17 |
| Date Mfgr Received | 2017-08-17 |
| Date Added to Maude | 2017-09-06 |
| 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 | DEROYAL |
| Generic Name | NECK ORTHOSIS |
| Product Code | IQK |
| Date Received | 2017-09-06 |
| Returned To Mfg | 2017-08-23 |
| Model Number | 14-103A-00 |
| Lot Number | 43184604 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INTERCONTINENTAL , S.R.L |
| Manufacturer Address | KM 7, AUTOPISTA JOAQUIN BALAGUER, PISANO FREE ZONE, 18 SANTIAGO, DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-06 |