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 2020-03-19 for 1.6MM COMPRESSION WIRE 30MM THREAD/150MM LENGTH 03.211.430 manufactured by Wrights Lane Synthes Usa Products Llc.
[188666776]
.product was not returned . based on the information available, it has been determined that no corrective and/or preventative action is proposed . this complaint will be accounted for and monitored via post market surveillance activities . if additional information is made available, the investigation will be updated as applicable . device history lot part: 03 .211 .430-us . lot: 2l61889 . manufacturing site: balsthal . release to warehouse date: 18 . dec . 2018 . a manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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
[188666777]
It was reported that on february 20, 2020, during insertion the compression wire broke off at the ball. Broken fragments were easily removed without additional intervention. There was a five (5) minute surgical delay. The procedure was successfully completed with another device. Patient outcome was unknown. This report is for one (1) 1. 6mm compression wire 30mm thread/150mm length. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01366 |
| MDR Report Key | 9855564 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2018-12-18 |
| Date Added to Maude | 2020-03-19 |
| 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 BALSTHAL (CH) |
| Manufacturer Street | DORNACHERSTRASSE 20 |
| Manufacturer City | BALSTHAL 4710 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4710 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.6MM COMPRESSION WIRE 30MM THREAD/150MM LENGTH |
| Generic Name | INSTRUMENT, COMPRESSION |
| Product Code | HWN |
| Date Received | 2020-03-19 |
| Model Number | 03.211.430 |
| Catalog Number | 03.211.430 |
| Lot Number | 2L61889 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-19 |