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 2020-03-31 for ZIMMER AIR DERMATOME 00880100100 manufactured by Zimmer Surgical, Inc..
[186722909]
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 reviews found no issues with the device and all verifications, inspections, and tests were successfully completed. On 13 january 2020, it was reported that the internal plastic rotor on a dermatome was loose and would not work. The customer returned a zimmer air dermatome serial number (b)(4) for evaluation. Evaluation of the device by zimmer (b)(4) on 13 january 2020 noted that the oscillator was broken and loose inside of the machined head, the head was worn, and that the depth bar had excessive side play. The device was forwarded to zimmer (b)(4) for further evaluation and repair. Evaluation of the device by zimmer (b)(4) on 22 january 2020 and found that the motor ran below motor speed specifications, and that the device was out of calibration at all four settings. Upon further evaluation, it was found that the neckpiece was broken and that the motor, multiple bearings, o-ring, seal, reciprocating arm, external e-ring, machined head, and the die cast lever were also defective. Repair of the dermatome occurred on 31 january 2020 and involved replacing the motor, multiple bearings, o-ring, seal, reciprocating arm, neckpiece assembly, external e-ring, machined head, and die cast lever. 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 dermatome had a broken reciprocating arm, which would cause the device to not produce the motor speed necessary to oscillate the blade properly, it cannot be determined from the information provided as to what caused the damage to the reciprocating arm. 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 procedure for any adverse trends that may warrant further action.
Patient Sequence No: 1, Text Type: N, H10
[186722910]
It was reported that the internal plastic rotor loose and would not work. Event occurred during sterile processing. During the investigation, it was discovered that the motor ran below motor speed specifications. No adverse event was reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00331 |
| MDR Report Key | 9903176 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 1999-03-01 |
| Date Added to Maude | 2020-03-31 |
| 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 | 3 |
| Brand Name | ZIMMER AIR DERMATOME |
| Generic Name | DERMATOME |
| Product Code | GFD |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-01-13 |
| Catalog Number | 00880100100 |
| Lot Number | 31938400 |
| 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 | 2020-03-31 |