MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-07 for SHAFT F/TREPHINE+EXTRACTION ATTACHMENT 03.111.030 manufactured by Wrights Lane Synthes Usa Products Llc.
[107864131]
Reportedly there was no patient involvement. Date of event is unknown. Device is an instrument and is not implanted/explanted. A device history record review was requested. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
[107864132]
It was reported that a shaft for trephine has a broken tine. This was discovered in sterile processing at the facility. The issue was then found during inspection of set at the loaners department. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-52062 |
| MDR Report Key | 7492375 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-07 |
| Date of Report | 2018-04-10 |
| Date Mfgr Received | 2018-06-06 |
| Device Manufacturer Date | 2012-02-20 |
| Date Added to Maude | 2018-05-07 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK BIO OBERDORF (CH) |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHAFT F/TREPHINE+EXTRACTION ATTACHMENT |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2018-05-07 |
| Returned To Mfg | 2018-04-10 |
| Catalog Number | 03.111.030 |
| Lot Number | 7727829 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-05-07 |