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

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Patient Device Interaction Problem (4001)

Patient Problem Abrasion (1689)

Event Date 07/13/2022

Event Type  Injury  

Event Description

It was reported that at the start of use the black catch that moves the knives back and forth was loose, and the dermatome was not functioning properly.A new leg skin had to be taken as the initial graft was damaged.A few minute delay occurred, and another device was used to complete procedure.No additional patient consequences were reported as a result of this malfunction.

Manufacturer Narrative

This incident has been recorded under (b)(4).Once investigation is completed a final/supplemental report will be submitted.

Manufacturer Narrative

The results of the investigation are as follows: review of the most recent repair record determined the blade movement was loose due to a broken neck pin and damaged back cover.Additionally, all the neck screws were broken off and stuck into the housing.The neck and neck screws were replaced.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• 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: 15140936
• MDR Text Key: 297002237
• Report Number: 0001526350-2022-00728
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024464834
• UDI-Public: (01)00889024464834(11)170504(10)63618116
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• 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: 88710100
• Device Lot Number: 63618116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2017
• 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
• Patient Outcome(s): Other