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.
[186562074]
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 pretest for check triggers. Therefore, the reported condition that the device was did not work was confirmed. The assignable root cause of this condition was determined to be traced to environmental issues. If additional information should become available, a supplemental medwatch report will be submitted accordingly. Udi? (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186562075]
It was reported from the (b)(6) that during service and evaluation, it was determined that the small battery drive device would not run, the coupling was worn, and there was cosmetic damage. It was noted that the device did not run and the markings were missing or nearly invisible. It was further determined that the device failed pretest for general condition, marking and labeling, check triggers, check the oscillation/forward/reverse mode function, and check power with test bench. It was noted in the service order that the device did not work at all. 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, however, it was reported that the event occurred in 2020. 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 | 8030965-2020-02305 |
| MDR Report Key | 9890851 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2014-11-21 |
| 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 | 2020-02-26 |
| 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 |