MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-28 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE 399.36 manufactured by Wrights Lane : Synthes Usa Products Llc.
[96221815]
No patient involvement was reported. Device is an instrument and is not implanted/explanted. (b)(6). Dhr review, part number: 399. 36 lot number: a7oa47), date of manufacture: dec 01, 2005, place of manufacture: (b)(6). Description of dhr review: a review of the device history record from the manufacturing site (b)(6) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. A review of inspection records and certifications confirm that the components and final product met inspection records and certification. All 200 parts of the lot were checked 100% for important features and for function at the final inspection on (b)(6) 2005 and found to be conforming. Customer quality conducted an investigation of the returned device. The returned instrument (part 399. 36, lot a7oa47, mfg dec 01, 2005) was inspected at customer quality and the complaint was confirmed. The instrument was returned with a crack migrating out from the dowel pin in the phenolic handle. Whether this complaint could be replicated is not applicable because the device was returned cracked. Investigation methods/evaluation results. A visual inspection, drawing and device history record review were performed as part of this investigation. Material and hardness testing is not applicable at this time as they were tested at the time of manufactured and confirmed to have no issues through the dhr review. Dimensional analysis is not applicable at this time as the dowel pin is deformed due to the manufacturing process. Upon visual inspection, it was noted that the phenolic handle had a crack migrating out of from the dowel pin. The crack measured 26. 71 mm long. Additionally, there was staining noted on the metal shaft and dowel pin. Drawing was reviewed and were determined to be suitable for the intended design, application and dimensional conformity when used as recommended. A review of the device history record from the manufacturing site (b)(6) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition therefor no further corrective and preventive actions are proposed. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[96221816]
It was reported that the handle on a synthes elevator is cracked. This issue was discovered outside of the operating room and there was no patient or procedure involvement. Investigation of the returned device also noted there was staining on the metal shaft and dowel pin. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2017-50470 |
| MDR Report Key | 7151348 |
| Date Received | 2017-12-28 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2017-12-27 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2017-12-28 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2017-12-28 |
| Returned To Mfg | 2017-11-28 |
| Model Number | 399.36 |
| Catalog Number | 399.36 |
| Lot Number | A7AO47 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE : SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-28 |