MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-31 for ZIMMER CAST SAW N/A 00889900100 manufactured by Zimmer Surgical, Inc..
[98980217]
This event has been recorded by zimmer biomet under (b)(4). On (b)(6) 2016, it was reported that the device was losing power during use and there was a smoky smell. The customer returned a zimmer biomet cast saw device, serial number (b)(4), for evaluation. The device history record (dhr) for the zimmer biomet cast saw, part number 00889900100 and serial number (b)(4), review could not be performed as the supplier was not able to provide the dhr. The device was manufactured more than seven years ago and the documentation is no longer required to be available as that is the life time of the device. Zimmer biomet surgical has not been previously repaired/evaluated zimmer biomet cast saw serial number (b)(4) as documented in the repair reports in livelink. Initial qa inspection of the zimmer biomet cast saw by zimmer biomet (b)(4) on december 9, 2016 revealed that the end of the cord needed repaired and there was 300mm of cord cut out from the cast cutter end. The brushes still had 95% left. The plaster dust build up needed blown out and the unit functioned as intended under load. Repair of the zimmer biomet cast saw was performed by zimmer biomet (b)(4) on december 9, 2016 which included repairing the cord and blowing out the plaster dust. Zimmer biomet cast saw, serial number (b)(4), was then tested and functioned properly. The device was repaired, inspected and tested. The root cause for the unit losing power during use and having a smoky smell was due the power cord needing repaired and 300mm of cord being cut from the cast cutter end. The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the power cord was repaired. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
Patient Sequence No: 1, Text Type: N, H10
[98980218]
It was reported as losing power during use, smokey smell. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2018-00110 |
| MDR Report Key | 7230739 |
| Date Received | 2018-01-31 |
| Date of Report | 2018-01-31 |
| Date Mfgr Received | 2018-01-31 |
| Date Added to Maude | 2018-01-31 |
| 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. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER SURGICAL, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZIMMER CAST SAW |
| Product Code | LGH |
| Date Received | 2018-01-31 |
| Returned To Mfg | 2016-12-09 |
| Model Number | N/A |
| Catalog Number | 00889900100 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-31 |