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 2018-01-15 for SHAFT F/TREPHINE+EXTRACTION ATTACHMENT 03.111.030 manufactured by Wrights Lane: Synthes Usa Products Llc.
[98014767]
No patient involvement. It is unknown when the event occurred. The 510k: this report is for a shaft - unknown lot. Device is an instrument and is not implanted/explanted. Complainant part has not been returned for manufacturer review/investigation. 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
[98014768]
It was reported that a shaft for trephine attachments fell and broke in sterile processing. This complaint involves one (1) part. This report is for one (1) shaft. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-50262 |
| MDR Report Key | 7192171 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-15 |
| Date of Report | 2017-12-18 |
| Date of Event | 2017-12-15 |
| Date Mfgr Received | 2018-02-12 |
| Device Manufacturer Date | 2010-06-08 |
| Date Added to Maude | 2018-01-15 |
| 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 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 | 0 |
| Brand Name | SHAFT F/TREPHINE+EXTRACTION ATTACHMENT |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2018-01-15 |
| Returned To Mfg | 2018-01-22 |
| Catalog Number | 03.111.030 |
| Lot Number | 2550856 |
| 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 | 2018-01-15 |