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 2019-02-07 for 1.5MM DRILL BIT/STRYKER J-LTCH WITH 12MM STOP/44.5MM 317.720 manufactured by Oberdorf Synthes Produktions Gmbh.
[136031737]
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
[136031738]
Device report from synthes reports an event in (b)(6) as follows: it was reported that a patient underwent an unknown surgery on (b)(6) 2019. During the surgery, the only drill bit available was used and broke upon handling. Before the procedure, it was noticed that only one drill bit was available inside the 2. 0 system which is supposed to have two (2) drill bits in it. This was noted not being safe for use due to not having another one to use. It is unknown if there was a surgical delay. Patient and procedure outcome are unknown. This report is for one (1) 1. 5mm drill bit/stryker j-latch with 12mm stop this is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-60713 |
| MDR Report Key | 8315297 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-07 |
| Date of Report | 2019-01-10 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2019-02-11 |
| Date Added to Maude | 2019-02-07 |
| 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 | 2019-02-07 |
| Catalog Number | 317.720 |
| 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 | 2019-02-07 |