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..
[182611041]
This event has been recorded under zimmer biomet complaint number (b)(4). On (b)(6) 2020, it was reported that during test and calibration unit, the device was found to be in need of repair. The device was sent in for pm only. The customer returned an air dermatome device, serial number (b)(4), for evaluation. The customer also returned a hose and 1"/2"/3"/4" width plates, for evaluation. Product review of the air dermatome on (b)(6) 2020 revealed that the motor speed was erratic. The control was in the correct position and the calibration was out of specifications at all settings. 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. While the returned product investigation confirmed that the air dermatome required repair, it cannot be determined from the information provided which component or combination of components caused the pm to escalate to a repair. A number of findings were noted during evaluation could have contributed to the reported event such as the calibration being out of specification at all settings and the motor running erratically. Therefore, based on the information provided, a specific root cause of the reported event cannot be determined. The device was not repaired as the customer did not respond to the repair quote. 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
[182611042]
It was reported during test and calibration unit, the device was found to be in need of repair. The customer sent this device in for pm only. The investigation identified that the motor speed was erratic. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00261 |
| MDR Report Key | 9801936 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 1999-08-30 |
| 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 | 2020-01-14 |
| Catalog Number | 00880100100 |
| Lot Number | 32091100 |
| 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 |