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 2018-07-30 for 2.0MM DRILL BIT W/DEPTH MARK QC/110MM 310.534 manufactured by Wrights Lane Synthes Usa Products Llc.
[115534751]
Additional narrative: device used in a veterinary case - no patient information will be reported. Device is an instrument and is not implanted/explanted. Date returned to manufacturer. (b)(6). A review of the device history records has been requested. Subject device has been received and is currently in the evaluation process. 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
[115534752]
This report is for a veterinary case. There was no human patient involvement. It was reported that during an unknown surgical tibial procedure of a sheep on (b)(6) 2018, the drill bit broke. The broken tip of the drill bit was not removed and remains embedded in the tibia. X-rays were taken. This report is for one (1) 2. 0mm drill bit. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-53121 |
| MDR Report Key | 7732766 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-30 |
| Date of Report | 2018-07-11 |
| Date of Event | 2018-07-11 |
| Date Mfgr Received | 2018-09-07 |
| Device Manufacturer Date | 2018-04-11 |
| 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 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 | 2.0MM DRILL BIT W/DEPTH MARK QC/110MM |
| Generic Name | BIT MILLING STERILE AND NON |
| Product Code | GFG |
| Date Received | 2018-07-30 |
| Returned To Mfg | 2018-07-25 |
| Catalog Number | 310.534 |
| Lot Number | L842387 |
| 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 | 2018-07-30 |