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 2020-03-27 for DRIVING CAP/THREADED 03.010.523 manufactured by Oberdorf Synthes Produktions Gmbh.
[186523517]
Reporter is company representative. Investigation summary. Picture review: narrative (driving cap broken and threaded tip stuck in insertion handle) could be verified from provided pictures. Investigation site: cq zuchwil selected flow: damaged - broken visual inspection: the threaded part of the driving cap is broken off below the last thread flank. The remaining thread flank is totally flattened, the black coating is not present anymore at the damage. The broken off part is still stuck in the receiving insertion handle and cannot be removed. In general, the driving cap presents hammer marks (dents) from hammering; otherwise, the part is in a good condition. Dimensional inspection: the relevant dimensions cannot be verified due to the damage incurred. Document/specification review: drawing se_380067 revision k was reviewed during this investigation. The review of the manufacturing documents has shown that with 1. 4542 stainless steel the correct material was used and that the hardness was within the specification. Inspection sheet of this lot pass all inspection steps during manufacturing without any deviations. Summary: the complaint condition is confirmed as the threaded tip of the driving cap is broken off. This production lot (l052029) was manufactured in october 2016 according to the specification. The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported. The correct material was used, and the hardness parameters were within the specifications. There were no issues during the manufacture of this product that would have contributed to this complaint condition. Based on the provided information? Damage noted during loan kit inspection - we are not able to determine the exact cause of this occurrence. However, it is most likely that any unintended excessive forces during use have contributed to the complaint condition. 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: 03. 010. 523 lot: l052029 manufacturing site: bettlach release to warehouse date: oct. 06, 2016 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
[186523518]
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the driving cap/threaded and radiolucent insertion handle frn was damaged. It was unknown if there was any surgery involved. The patient status unknown. This complaint involves two (2) devices. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02369 |
| MDR Report Key | 9891394 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-02 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2016-10-06 |
| Date Added to Maude | 2020-03-27 |
| 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 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 | DRIVING CAP/THREADED |
| Generic Name | MISC ORTHO SURGICAL INSTR |
| Product Code | LXH |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-10 |
| Catalog Number | 03.010.523 |
| Lot Number | L052029 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-27 |