MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-20 for LARGE HANDLE WITH QUICK COUPLING 311.431 manufactured by Wrights Lane Synthes Usa Products Llc.
[186757759]
Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. A review of the device history record has been requested. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. 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
[186757760]
It was reported that on an unknown date, during a routine incoming inspection of a loaner set, it was observed that a handle with quick coupling was broken. There was no known patient or hospital involvement. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01423 |
| MDR Report Key | 9861742 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2016-10-06 |
| Date Added to Maude | 2020-03-20 |
| 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 | 3 |
| Brand Name | LARGE HANDLE WITH QUICK COUPLING |
| Generic Name | TAP,BONE |
| Product Code | HWX |
| Date Received | 2020-03-20 |
| Model Number | 311.431 |
| Catalog Number | 311.431 |
| Lot Number | L133782 |
| 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 | 2020-03-20 |