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

Model Number N/A

Device Problems Failure to Cut (2587); Patient Device Interaction Problem (4001)

Patient Problems Laceration(s) (1946); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.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

It was reported that its tearing up and the doner site and graft.The event timing is during surgery.It is unknown at this time if there was any impact to the patient.Due diligence is in progress.

Event Description

There was a delay.The graft site was mutilated.Unable to use and had to attempt to take multiple pieces from other sites that was also not ideal.Diligence is complete.

Manufacturer Narrative

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.

Manufacturer Narrative

Review of the most recent repair record determined the reported cutting issue could not be replicated; however, the reciprocating arm was worn which could affect device functionality.The reciprocating arm and bearings were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing 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.

Event Description

There is 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: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19106228
• MDR Text Key: 340162633
• Report Number: 0001526350-2024-00442
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024464834
• UDI-Public: (01)00889024464834(11)210223(10)65017322
• 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,Followup,Followup
• Report Date: 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 65017322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: Not provided; 04/30/2024
• Supplement Dates FDA Received: 04/19/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNK BLADE
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Prefer Not To Disclose