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

Model Number N/A

Device Problem Fitting Problem (2183)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

It was reported that outside of surgery, the blade of the device fell too far back causing the graft thickness adjustment to be inconsistent.There was no patient involvement and as a result no harm or delay were reported.No adverse event was reported as it relates to the event.

Manufacturer Narrative

This incident has been recorded under (b)(4).Upon completion of investigation, a final/supplemental report will be submitted.

Event Description

No additional information is available.

Manufacturer Narrative

This incident has been recorded under (b)(4).Review of the most recent repair record determined the device was out of calibration.The device was recalibrated and the thickness control shaft, sleeve bearings, shaft bearings, and one neck cap screw were replaced to aid in proper calibration and resolved the reported issue.Dhr was reviewed and no discrepancies related to the reported event were found.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• 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: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15666113
• MDR Text Key: 306599784
• Report Number: 0001526350-2022-01032
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024464834
• UDI-Public: (01)00889024464834(11)170310(10)63578131
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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: 63578131
• 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: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• 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