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 2018-05-03 for 2.0MM DRILL BIT WITH DEPTH MARK/QC/110MM 310.534 manufactured by Oberdorf Synthes Produktions Gmbh.
[107203583]
No patient involvement reported. Event date was reported as (b)(6) 2018 it unknown if the date is when the device broke or when it was found broken. Device is an instrument and is not implanted / explanted. Reporter contact facility number was not provided. The device was received and the product evaluation is in progress. No conclusion can be drawn. 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
[107203584]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that when the drill set was returned to the loan department by the customer, the drill was broken. No patient involvement reported. This report is for one (1) 2. 0mm drill bit with depth mark/qc/110mm. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-53504 |
| MDR Report Key | 7482637 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-03 |
| Date of Report | 2018-04-12 |
| Date Mfgr Received | 2018-07-06 |
| Device Manufacturer Date | 2010-08-31 |
| Date Added to Maude | 2018-05-03 |
| 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 | 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 | 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 WITH DEPTH MARK/QC/110MM |
| Generic Name | BIT MILLING STERILE AND NON |
| Product Code | GFG |
| Date Received | 2018-05-03 |
| Returned To Mfg | 2018-04-20 |
| Catalog Number | 310.534 |
| Lot Number | F-10049 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-03 |