MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-01-27 for CURVED OSTEOTOME N/A 00705300301 manufactured by Zimmer Tmt.
[176658133]
(b)(4). Complaint sample was evaluated and the reported event was confirmed. Visual examination of the returned device identified that the clamping screw was no longer functioning as intended, as it would not tighten. The hex threads inside the screw were damaged likely from tightening the screw. The device had an approximate field life of 3 years. Device history record (dhr) was reviewed and no discrepancies were found. Root cause was unable to be determined. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. Report source: event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[176658154]
It was reported that during a primary tha, the instrument would not hold the blade component. The surgeon was unable to use the device and proceeded to use a chisel for surgery. This resulted in a 31-60 minute delay in surgery. Attempts have been made and no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005751028-2020-00008 |
| MDR Report Key | 9631457 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-27 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2016-06-10 |
| Date Added to Maude | 2020-01-27 |
| 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 | MR. WILLIAM HARA |
| Manufacturer Street | 10 POMEROY ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9735760032 |
| Manufacturer G1 | ZIMMER TMT |
| Manufacturer Street | 10 POMEROY ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CURVED OSTEOTOME |
| Generic Name | INSTRUMENT, SURGICAL |
| Product Code | HWM |
| Date Received | 2020-01-27 |
| Returned To Mfg | 2019-11-18 |
| Model Number | N/A |
| Catalog Number | 00705300301 |
| Lot Number | 63396488 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER TMT |
| Manufacturer Address | 10 POMEROY ROAD PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-27 |