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

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during surgery the dermatome was running but did not cut through the skin.There was no harm or delay reported.Even though there was damage to the harvested skin, the graft harvest was able to be used.An alternate device was available for use to complete the procedure.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).D4 udi: (b)(4).Review of the most recent repair record determined the motor was slow and depth bar had side play.The motor was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.A definitive root cause cannot be determined.The event cannot be confirmed.

Event Description

No additional event information available.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10338959
• MDR Text Key: 200818649
• Report Number: 0001526350-2020-00638
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• 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: 00882100100
• Device Lot Number: 63817649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1