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

Model Number N/A

Device Problems Incorrect Measurement (1383); Failure to Cut (2587)

Patient Problem Abrasion (1689)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the device did not perform as expected.It tore into muscle and chewed skin during surgery in (b)(6) of 2020.No additional information is available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the rpms were erratic, the control bar was not in the correct position, and the calibration was out.The spring seal was stretched and the control bar, thickness control shaft, fine adjustment cams, vespel bearing, and semi-circle bearing were replaced which resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.

• 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: 11219025
• MDR Text Key: 228471417
• Report Number: 0001526350-2021-00078
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00882100100
• Device Lot Number: 61378606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other