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 2020-03-27 for COLIBRI II 532.101 manufactured by Depuy Synthes Products Llc.
[186536873]
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. The actual device was returned for evaluation. During repair, an evaluation was performed and it was determined that the device failed pre-test for check for sticky speed trigger, and check triggers. Therefore, the reported condition that the ecu did not function and the device had a sticky trigger was confirmed. The assignable root cause of this condition was determined to be traced to component failure due to normal wear. Udi? (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186536874]
It was reported from (b)(6) that during service and evaluation, it was determined that the small battery drive device would not run, the electronic control unit (ecu) was damaged, and the motor was worn. It was further determined that the device failed pretest for check the oscillation/forward/reverse mode function, check the oscillation angle, check switching function forward/reverse, check power with test bench, check for sticky speed trigger, and check triggers. It was noted in the service order that the ecu did not function. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was not reported. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02334 |
| MDR Report Key | 9891193 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-19 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2016-06-15 |
| Date Added to Maude | 2020-03-27 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLIBRI II |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT |
| Product Code | HWE |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-02 |
| Catalog Number | 532.101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |