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 2019-02-13 for 2.0MM DRILL BIT W/DEPTH MARK QC/110MM 310.534 manufactured by Oberdorf Synthes Produktions Gmbh.
[136774042]
Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. 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
[136774043]
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a tarso-metatarsal joint (tmtj) fusion of the left foot procedure on (b)(6) 2019, a 2. 0mm drill bit from variable angle forefoot/midfoot set broke off in patient due to the use of excessive force of the surgeon while drilling into the bone of the patient. . The broken piece was retrieved, and the drill bit was discarded. The procedure was completed without surgical delay and patient consequences. This report is for one (1) 2. 0mm drill bit w/depth mark. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-60973 |
| MDR Report Key | 8336573 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-13 |
| Date of Report | 2019-01-23 |
| Date of Event | 2019-01-23 |
| Date Mfgr Received | 2019-01-23 |
| Date Added to Maude | 2019-02-13 |
| 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 | 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 | 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 | 2019-02-13 |
| Catalog Number | 310.534 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-02-13 |