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

Model Number N/A

Device Problems Unstable (1667); Failure to Cut (2587); Patient Device Interaction Problem (4001)

Patient Problems Abrasion (1689); Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  Injury  

Manufacturer Narrative

An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.E1: telephone: (b)(6).G2: foreign: united kingdom.

Event Description

It was reported that during surgery, the dermatome was skipping on the skin.It was unknown if there was patient harm or surgical delay.Due diligence is in progress, no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.The following sections have been updated/corrected: an investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.

Event Description

It was reported that during surgery, the dermatome was skipping on the skin.The dermatome worked inconsistent at the end of the case taking uneven and tearing the skin, even when the blade was renewed, and the same technique had been used throughout the case.The device malfunction occurred prior to the initial use of a brand-new device.There was no patient harm/ injury.The harvest site did not need unexpected surgical intervention such as suture however, extra skin was harvested.It was a major procedure so unable to say precisely how much skin would be needed only an estimate.The taken graft was damaged, it was torn into a few pieces.There was no medical intervention/additional surgical procedure required.There was a 10-minute delay as they waited for another dermatome and set it up to complete the surgery.The patient was under anesthesia during this delay.The surgical technique for the product utilized.Due diligence is complete, no additional information is available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the unit was out of calibration at the 0,10 and 20 readings and the position of the control bar was not correct.The screws, shaft bearings and sleeve bearings were replaced and the unit was re-calibrated 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 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.

Event Description

There is no additional information available.

• Brand Name: ZIMMER AIR DERMATOME
• 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: 17365046
• MDR Text Key: 319451922
• Report Number: 0001526350-2023-00780
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375901
• UDI-Public: (01)00889024375901(11)220926(10)65662349
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• 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: 00880100100
• Device Lot Number: 65662349
• 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: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• 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
• Treatment: UNK BLADESN: UNK
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Prefer Not To Disclose