MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-30 for ZIMMER AIR DERMATOME, COMPLETE 00880100000 manufactured by Zimmer Surgical, Inc..
[186597668]
This event has been recorded under zimmer biomet complaint number (b)(4). The reported event was confirmed by the service technician who performed the evaluation and repair. On 15 october 2019, it was reported that a dermatome was not working properly. The customer returned a zimmer air dermatome serial number (b)(4) for evaluation. Evaluation of the device on 28 october 2019 noted that the dermatome was out of calibration at the zero and twenty settings and that the motor ran erratically. Upon further inspection, it was found that the swivel was loose. Repair of the dermatome occurred on 18 december 2019 and involved replacing the motor, swivel, multiple bearings, and the throttle hinge as well as recalibrating the device. The technician then tested and verified that the device was functioning as intended, then returned the device to the customer without further incident. The device was tested, inspected, and repaired. While the service technician found that the swivel was loose, that the device was running below motor speed specifications, and that the dermatome was out of calibration specification at the zero and twenty settings, all failure modes that would cause the device to not function as intended, it cannot be determined from the information provided as to what caused these failures to occur. As such, a specific root cause of the reported event cannot be determined. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process. Review of the information provided during the investigation determined that there are no further actions needed at this time. This complaint will be tracked and trended for any adverse trends that may warrant further action.
Patient Sequence No: 1, Text Type: N, H10
[186597669]
It was reported that the device does not work. Event occurred during kit inspection before surgery. This event was identified immediately after receipt of recent repair. Upon investigation, it was determined that the motor ran erratically. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00326 |
| MDR Report Key | 9900441 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-10-14 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 1996-08-05 |
| Date Added to Maude | 2020-03-30 |
| 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, COMPLETE |
| Generic Name | DERMATOME |
| Product Code | GFD |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2019-10-24 |
| Catalog Number | 00880100000 |
| Lot Number | 31067200 |
| 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 | 2020-03-30 |