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

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Cut (2587)

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

Event Date 11/24/2021

Event Type  malfunction  

Event Description

It was reported that the graft was thicker than expected.The event occurred during surgery.There was no report of harm or delay.No adverse event was reported as a result of this 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.

Manufacturer Narrative

This complaint has been recorded under (b)(4).Review of the most recent repair record identified no repairs related to the reported event.The rpm's and calibration were in specification and the position of the control bar was correct.A definitive root cause cannot be determined.The reported event could not be duplicated.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.

Event Description

No additional information available.

• Brand Name: DERMATOME AN HANDPIECE
• 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: 13051287
• MDR Text Key: 282555949
• Report Number: 0001526350-2021-01370
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: 63578135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1