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 2019-05-08 for 2.0MM DRILL BIT W/DEPTH MARK QC/110MM 310.534 manufactured by Oberdorf Synthes Produktions Gmbh.
[144434929]
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Concomitant medical products: drill (part: unknown, lot: unknown, quantity: 1)? (b)(6) 2019. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[144434930]
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent a foot arthrodesis. During the procedure, a drill bit broke at its distal portion while being used. It was not possible to remove the drill bit completely; a very small fragment, the tip of the drill bit, remained in the bone. Another drill bit from the same box was used to continue the procedure. The procedure was successfully completed with no reported surgical delay. There was no damage to the patient. Concomitant devices: drill (part: unknown, lot: unknown, quantity: 1). This report is for a 2. 0mm drill bit w/depth mark. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-63638 |
| MDR Report Key | 8591409 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-04-10 |
| Date Mfgr Received | 2019-05-28 |
| Device Manufacturer Date | 2010-08-04 |
| Date Added to Maude | 2019-05-08 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | SYNTHES SELZACH |
| Manufacturer Street | BOHACKERWEG 5 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| 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 |
| Product Code | GFG |
| Date Received | 2019-05-08 |
| Model Number | 310.534 |
| Catalog Number | 310.534 |
| Lot Number | F-10271 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-05-08 |