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 2018-10-29 for 3.8MM THREE-FLUTED DRILL BIT QC/CALIBRATED/270MM 03.019.016 manufactured by Oberdorf Synthes Produktions Gmbh.
[125350173]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. 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. The investigation could not be completed; no conclusion could be drawn. 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.
Patient Sequence No: 1, Text Type: N, H10
[125350174]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, patient underwent an orthopedic procedure. When the specialist performed a proximal block, the drill bit split, and the fragment remained in the patient. It is unknown if there was a surgical delay. There was an unknown patient consequence reported. Procedure outcome was unknown. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-57724 |
| MDR Report Key | 8015876 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-29 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-10-10 |
| Date Mfgr Received | 2019-01-03 |
| Date Added to Maude | 2018-10-29 |
| 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 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| 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 | 3.8MM THREE-FLUTED DRILL BIT QC/CALIBRATED/270MM |
| Generic Name | BIT |
| Product Code | GFG |
| Date Received | 2018-10-29 |
| Catalog Number | 03.019.016 |
| 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 | 2018-10-29 |