MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-06 for ZIMMER AIR DERMATOME 00880100100 manufactured by Zimmer Surgical, Inc..
[182612178]
This event has been recorded under zimmer biomet complaint number (b)(4). On (b)(6) 2020, it was reported that during pm it was found that the dermatome was in need of repair as it was leaking oil. The customer returned an air dermatome device, serial number (b)(4), for evaluation. Product review of the air dermatome on (b)(6) 2020 revealed that the motor speed was out of specifications. The control bar was not in the correct position and the calibration was out at the 0, 10, and 20 settings. The head had damage that could affect the performance of the device. The control bar and reciprocating arms had visible damage. The customer hose and width plates were not returned for evaluation. Repair of the air dermatome has not been performed by zimmer biomet surgical as the device is aged and the customer was unresponsive so the device will be returned to them unrepaired. The root cause of the reported event cannot be specifically determined with the provided information because the reported event was non-verifiable. 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
[182612179]
It was reported that during pm it was found that the dermatome was in need of repair for unknown reason. The device was leaking oil. The investigation identified that the motor speed performed below specifications. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00259 |
| MDR Report Key | 9801917 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2005-06-02 |
| Date Added to Maude | 2020-03-06 |
| 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 | 3 |
| Brand Name | ZIMMER AIR DERMATOME |
| Generic Name | DERMATOME |
| Product Code | GFD |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-02-11 |
| Catalog Number | 00880100100 |
| Lot Number | 60275784 |
| 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 | 2020-03-06 |