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 2019-03-14 for 1.5MM DRILL BIT/STRYKER J-LTCH WITH 12MM STOP/44.5MM 317.720 manufactured by Oberdorf Synthes Produktions Gmbh.
[138895870]
Complainant part is not expected to be returned for manufacturer review/investigation. 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
[138895871]
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent an ortognatica procedure. During the procedure, a drill bit broke during handling. There were no fragments generated from the broken device and procedure was completed using another drill bit of the same size. The procedure was successfully completed with no surgical delay. There was no patient consequence. This report is for a 1. 5mm drill bit. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-61964 |
| MDR Report Key | 8421951 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-14 |
| Date of Report | 2019-02-20 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-04-08 |
| Device Manufacturer Date | 2016-03-17 |
| Date Added to Maude | 2019-03-14 |
| 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 | 1.5MM DRILL BIT/STRYKER J-LTCH WITH 12MM STOP/44.5MM |
| Generic Name | DRILL, BONE, POWERED |
| Product Code | DZI |
| Date Received | 2019-03-14 |
| Catalog Number | 317.720 |
| Lot Number | F-19648 |
| 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 | 2019-03-14 |