MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-10 for BONE HARVESTING TREPHINE STYLET 03.111.031 manufactured by Wrights Lane Synthes Usa Products Llc.
[159796153]
Device received. A review of the device history record. Device history lot: part: 03. 111. 031. Lot: l227486 manufacturing site: (b)(4). Release to warehouse date: 23. Dec. 2016. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. Investigation summary background: it was reported on an unknown date that bone harvesting trephine stylet was found bent when putting up set. There is no patient involvement. This complaint involves (1) patient. Investigation flow: damage. Visual inspection: the bone harvesting trephine stylet (p/n 03. 111. 031. Lot l227486). Was received showing the shaft bent. No other issues were identified. Dimensional inspection: drawing: stylet trephine orthopedic foot se_195176 rev c. Document/specification review: the following drawings, reflecting the manufactured and current revision, were reviewed. Stylet trephine orthopedic foot se_195176 rev c/d during the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. Conclusion: the complaint condition is confirmed for the bone harvesting trephine stylet (p/n 03. 111. 031 lot l227486) as the shaft was bent. While no definitive root cause could be determined, it is possible that the device encountered unintended bending forces. During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Based on the investigation findings, it has been determined that no corrective and/or preventative action is 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
[159796294]
It was reported on an unknown date that bone harvesting trephine stylet was found bent when putting up set. There is no patient involvement. This complaint involves (1) patient. This report is 1 of 1 for...
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-60429 |
| MDR Report Key | 8983282 |
| Date Received | 2019-09-10 |
| Date of Report | 2019-08-13 |
| Date Mfgr Received | 2019-08-13 |
| Device Manufacturer Date | 2016-12-23 |
| Date Added to Maude | 2019-09-10 |
| 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 | 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 BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BONE HARVESTING TREPHINE STYLET |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2019-09-10 |
| Returned To Mfg | 2019-08-26 |
| Model Number | 03.111.031 |
| Catalog Number | 03.111.031 |
| Lot Number | L227486 |
| 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 | 2019-09-10 |