MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-05 for ZIMMER AIR DERMATOME N/A 00880100100 manufactured by Zimmer Surgical, Inc..
[183920048]
This event has been recorded by zimmer biomet under (b)(4). The device history record for zimmer air dermatome serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with the device. The record review found no issues with the device and all verifications, inspections, and tests were successfully completed. On (b)(6) 2019, it was reported that a dermatome needed to be repaired. A zimmer air dermatome serial number (b)(4) was already at a zimmer facility and was available for evaluation. Evaluation of the device on (b)(6) 2019 noted that the device was out of calibration at the zero setting and was outside of motor speed specifications and ran erratically. Upon further evaluation, it was found that the machined head and the control bar were damaged. Repair of the dermatome occurred the same day and involved replacing the machined head, control bar, multiple bearings, motor, swivel, and the poppet assembly. The technician then tested and verified that the dermatome 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 device ran below motor speed specifications, had a defective control bar and machined head, and was out of calibration specifications, all failures that would require service in order to resolve, it cannot be determined from the information provided as to what caused these failure with the device. 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.
Patient Sequence No: 1, Text Type: N, H10
[183920049]
It was reported that the device was sent in for inspection and was found in need of repair. Investigation showed the device was out of motor speed specifications. No adverse event was reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00252 |
| MDR Report Key | 9792592 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2011-11-28 |
| Date Added to Maude | 2020-03-05 |
| 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 | 2020-03-05 |
| Returned To Mfg | 2019-12-03 |
| Model Number | N/A |
| Catalog Number | 00880100100 |
| Lot Number | 61919647 |
| 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 | 2020-03-05 |