MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER AIR DERMATOME

Model Number N/A

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental medwatch will be filed.

Event Description

It was reported that the motor was running slow.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.On november 10, 2019, it was reported that the motor was running slow.The customer returned an air dermatome device, serial number (b)(6), for evaluation.The device history record (dhr) and previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed.Product review of the air dermatome by zimmer biomet taiwan on november 21, 2019 revealed that the device operated within motor speed specifications but at the lower end.Repair of the air dermatome was performed by zimmer biomet taiwan on november 22, 2019 which included replacement of the motor, bearings, o-ring, seal, reciprocating arm, external e-ring and width plate screws.Air dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review by zimmer biomet taiwan it was noted that the device operated within motor speed specifications but was at the lower end of the specification.It is unknown with the information that was provided how this occurred.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 (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9413304
• MDR Text Key: 197750114
• Report Number: 0001526350-2019-01108
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880100100
• Device Lot Number: 61396387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1