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 2018-05-14 for SHAFT FOR TREPHINE ATTACHMENTS 03.111.030 manufactured by Wrights Lane Synthes Usa Products Llc.
[108370583]
Patient? S height reported as 183. 50 cms. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter phone number is not provided for reporting. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested and is currently pending completion. 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
[108370584]
It was reported that in a surgery on (b)(6) 2018 while the doctor was gathering bone from the calcaneus with the trephine attachment, the three prongs of the trephine attachment snapped off. No fragments were generated from the broken device. Also, while the doctor went to plunge the bone out of the guide wire the bone was stuck on the attachment and the plunger bent. The case was delayed about 5 minutes due to this. There was no harm to the patient. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-52171 |
| MDR Report Key | 7512780 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-14 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-06-21 |
| Device Manufacturer Date | 2016-02-17 |
| Date Added to Maude | 2018-05-14 |
| 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 | MR. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| 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 | SHAFT FOR TREPHINE ATTACHMENTS |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2018-05-14 |
| Returned To Mfg | 2018-05-18 |
| Catalog Number | 03.111.030 |
| Lot Number | 9763178 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-05-14 |