MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME AN HANDPIECE; DERMATOME, PNEUMATICALLY-POWERED

Model Number N/A

Device Problem Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  malfunction  

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.

Event Description

It was reported that the dermatome thickness was not accurate and the surgeon had to modify/guess the thickness for it¿s accuracy.Hospital has reported two dermatomes because they are unsure which one is problematic.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Pn 88710100 (ln 64803586).It was reported the dermatome thickness was not accurate and the surgeon had to modify/guess the thickness for it¿s accuracy; however, the device will not be repaired as the location is unknown.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history identified additional similar complaints for the reported item and part and lot combination.Complaints are monitored through monthly complaint review (reference (b)(4) and (b)(4) in order to identify potential adverse trends.H3 other text: not returned.

Event Description

It was reported that the dermatome thickness was not accurate and the surgeon had to modify/guess the thickness for it¿s accuracy.Hospital is still unsure which of the devices malfunctioned.This is being filed to cover the malfunctioning device.

• Brand Name: DERMATOME AN HANDPIECE
• Type of Device: DERMATOME, PNEUMATICALLY-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 11709266
• MDR Text Key: 247495500
• Report Number: 0001526350-2021-00476
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• 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: 88710100
• Device Lot Number: 64803586
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1