MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-30 for TREPHINE ATTACHMENT 5.5MM DIAMETER 03.111.025 manufactured by Wrights Lane Synthes Usa Products Llc.
[115366497]
Patient information is unknown. Date of event is an unknown date in (b)(6) 2018. Lot number is unknown. Device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter phone number and email address are unavailable. Reporter is a synthes sales consultant. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[115366498]
It was reported that during an unknown orthopedic procedure in (b)(6) 2018, the trephine attachment 7. 0mm and trephine attachment 5. 5mm diameter broke off in the patient during a procedure; most of the fragments were removed, but some fragments were left inside the patient. It is unknown if there were any surgical delay. Patient outcome is unknown. This report is for a trephine attachment 5. 5mm diameter. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-53114 |
| MDR Report Key | 7731091 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-30 |
| Date of Report | 2018-07-12 |
| Date Mfgr Received | 2018-08-16 |
| Date Added to Maude | 2018-07-30 |
| 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 | 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 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 | TREPHINE ATTACHMENT 5.5MM DIAMETER |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2018-07-30 |
| Catalog Number | 03.111.025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2018-07-30 |