MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for SYNFRAME HALF RING 387.337 manufactured by Oberdorf Synthes Produktions Gmbh.
[186553572]
The visual inspection of the returned synframe half ring has shown that the locking screw is damaged at the threaded shaft as well the hexagonal recess is badly widened. All in all the device is in very used condition and there are wear marks and scratches visible all over the surface. A functional test cannot be performed of the detected damage. The damaged thread of the locking screw prevent a proper tightened of the connection with the other synframe half ring. The received condition agree with the complaint description and the complaint therefore is confirmed. The investigation has shown that the locking screw is damaged at the threaded shaft as well the hexagonal recess is badly widened. All in all the device is in very used condition and there are wear marks and scratches visible all over the surface. The damaged thread of the locking screw prevent a proper tightened of the connection with the other synframe half ring. The damage incurred is determined to be post production. The damaged locking screw is a clear indication, that the product was used in an excessive way over the years. We do suppose that the cause of the damages are the result of a several mechanical overload situation during use. During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required. The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps "dimensional inspection:" are not required. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected. Device history lot part: 50131166 lot: 1941932 manufacturing site: (b)(4) release to warehouse date: 08. July. 2008 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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
[186553573]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the synframe sent had a damaged part on it. The synframe has a large ring which is held together by screws on its diameter. There is an issue with the locking screws that means the ring was not stable during use. No patient involvement reported. This report is for one (1) synframe half ring this is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02399 |
| MDR Report Key | 9897585 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK H |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNFRAME HALF RING |
| Generic Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Product Code | LXH |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-02-27 |
| Catalog Number | 387.337 |
| Lot Number | 1941932 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |