MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME AN HANDPIECE; DERMATOME HANDPIECE, PNEUMATIC

Model Number N/A

Device Problem Failure to Cut (2587)

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

Event Date 07/11/2022

Event Type  malfunction  

Event Description

It was reported that outside of surgery the dermatome kept skipping and had inconsistent blade movement.No patient involvement was noted.As a result, no harm or delay were reported.No adverse event was reported as it relates to this event.No additional information is available.

Manufacturer Narrative

This incident has been recorded under (b)(4).Review of the most recent repair record identified no repairs related to the reported event.A definitive root cause cannot be determined.The event cannot be 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.

• Brand Name: DERMATOME AN HANDPIECE
• Type of Device: DERMATOME HANDPIECE, PNEUMATIC
• 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: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16026832
• MDR Text Key: 306212273
• Report Number: 0001526350-2022-01221
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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: 88710100
• Device Lot Number: 65340075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2021
• 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