MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-10-12 for 2.0MM DRILL BIT W/DEPTH MARK QC/110MM 310.534 manufactured by Oberdorf Synthes Produktions Gmbh.
[123565935]
A review of the device history records has been requested. The device has been received; the investigation is in progress. No conclusion could be drawn at the time of filing this report. 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
[123565936]
Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent open reduction internal fixation (orif) surgery for distal radius fracture in the right arm with drill bit with marking on (b)(6) 2018. When the surgeon was drilling the contralateral cortical bone, the drill bit punctured the skin. The surgeon then hastily pulled out the drill and the drill bit broke outside the body. It was confirmed that there was no fragment left in the patient? S body by x-rays during the surgery and after the surgery. The procedure was completed successfully. There was no surgical delay and no adverse consequence to the patient reported. Concomitant device reported: drill (part# unknown, lot# unknown, quantity# 1). This report is for one (1) 2. 0mm drill bit. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-57274 |
| MDR Report Key | 7961715 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-12 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-27 |
| Date Mfgr Received | 2018-11-22 |
| Device Manufacturer Date | 2017-06-14 |
| Date Added to Maude | 2018-10-12 |
| 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 | 2.0MM DRILL BIT W/DEPTH MARK QC/110MM |
| Generic Name | BIT MILLING STERILE AND NON |
| Product Code | GFG |
| Date Received | 2018-10-12 |
| Returned To Mfg | 2018-10-05 |
| Catalog Number | 310.534 |
| Lot Number | L452638 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-12 |