MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-31 for BUTTRESS/COMPRESSION NUT FOR 357.369 357.371 manufactured by Wrights Lane Synthes Usa Products Llc.
[131715759]
Initial reporter is synthes sales consultant. Device history lot part number: 357. 371, synthes lot number: 7638321, supplier lot number: 7638321, release to warehouse date: 11-jun-2014, manufacturing site: synthes monument. Supplier: (b)(4). No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition. Investigation summary: the buttress/compression nut does thread properly on a blade guide sleeve thread, it gets stuck at the top of the guide sleeve. There was no patient involvement. Visual inspection: the buttress/ compression nut for 357. 369 (part # 357. 371, lot # 7638321, mfg # 11-jun-2014) was received with the buttress/compression nut stuck at the top of the blade guide sleeve. The buttress nut shows signs of minimal wear. Functional test: the buttress/compression nut is stuck at the top of the blade guide sleeve and the two parts are unable to be separated. The complaint was not able to be replicated since the buttress nut cannot be unscrewed from the blade sleeve and screwed on again. This is consistent with the reported complaint condition, thus confirming the complaint. Dimensional inspection: dimensional analysis was not able to be performed since the buttress nut is stuck and unable to be separated. Therefore, no relevant dimensions could be measured. Conclusion: the complaint condition is confirmed as the buttress nut (part # 357. 371, lot # 7638321) was received stuck at the top of the blade guide sleeve. There is no indication that a design or manufacturing issue contributed to the complaint. While no definitive root cause could be determined it is possible that the device encountered unintended forces. No new malfunctions were observed during the course of this investigation. 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
[131715760]
It was reported that on (b)(6) 2018, helical blade inserter top screw (connecting screw) is not functioning properly, it won't screw in and lock the gold handle in places. In addition, the buttress/compression nut does thread properly on a blade guide sleeve thread, it gets stuck at the top of the guide sleeve. There was not patient involvement. This report is for one (1) buttress/compression nut for 357. 369. This is report 4 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-55642 |
| MDR Report Key | 8206147 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-31 |
| Date of Report | 2018-12-27 |
| Date of Event | 2018-11-03 |
| Date Mfgr Received | 2018-12-27 |
| Device Manufacturer Date | 2014-06-11 |
| Date Added to Maude | 2018-12-31 |
| 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 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUTTRESS/COMPRESSION NUT FOR 357.369 |
| Generic Name | TRACTION,APPARATUS,NON-POWERED |
| Product Code | HST |
| Date Received | 2018-12-31 |
| Returned To Mfg | 2018-11-14 |
| Catalog Number | 357.371 |
| Lot Number | 7638321 |
| 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 | 2018-12-31 |