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

Model Number N/A

Device Problems Incorrect Measurement (1383); Failure to Cut (2587); Patient Device Interaction Problem (4001)

Patient Problem Abrasion (1689)

Event Date 06/19/2023

Event Type  Injury  

Event Description

It was reported that during surgery, the dermatome took a skin graft that was too thick with setting 12.There was harm to the patient as an additional skin graft was taken.There was a 35-minute delay.No additional patient consequences were reported as a result of this malfunction.As the customer has indicated that no additional information is available, due diligence is complete.

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.Telephone: (b)(6).Foreign: finland.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record identified no repairs related to the reported event.The reported issue could not be replicated; no problem found.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: 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: 17268073
• MDR Text Key: 318508727
• Report Number: 0001526350-2023-00699
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• 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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Prefer Not To Disclose