MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER ELECTRIC DERMATOME HP

Model Number N/A

Device Problems Loss of Power (1475); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2022

Event Type  malfunction  

Event Description

It was reported that the dermatome was losing power, and caused damage to a taken graft.Harm was noted but details are unavailable.There was a delay of 10 minutes, and no additional graft was taken.No other adverse events were noted to have occurred.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.

Manufacturer Narrative

This complaint has been submitted under (b)(4).Review of the most recent repair record determined the motor speed was unstable, the compression cap and width plate screws had failed, and the unit was out of calibration.The motor, compression cap, width plate screws, shaft bearings, and sleeve bearings were replaced and the unit was calibrated to resolve the reported issue.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional information is available.

• Brand Name: ZIMMER ELECTRIC DERMATOME HP
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13314295
• MDR Text Key: 284179786
• Report Number: 0001526350-2022-00060
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375994
• UDI-Public: (01)00889024375994(11)170104(10)63526314
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• 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: 00-8821-001-00
• Device Lot Number: 63526314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1