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

Model Number N/A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Cut (2587); Calibration Problem (2890); Patient Device Interaction Problem (4001)

Patient Problems Abrasion (1689); Unspecified Tissue Injury (4559)

Event Date 07/26/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer has indicated that the product will be returned to zimmer biomet and the investigation is in process.Once the investigation has been completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during surgery the device had uneven thickness, and the thickness did not match setting depth and calibration way off.The grafts were poorly harvested and additional skin had to be harvested.There was a 30-40 minute delay and the patient was underanesthesia.No additional patient consequences were reported as a result of this malfunction.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.The results of the investigation are as follows: - review of the most recent repair record identified no repairs 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 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: 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: 15279387
• MDR Text Key: 298439821
• Report Number: 0001526350-2022-00821
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 00889024375901
• UDI-Public: (01)00889024375901(11)211215(10)65354789
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• 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: 00880100100
• Device Lot Number: 65354789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2021
• 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 Age: 27 YR
• Patient Sex: Male
• Patient Weight: 74 KG