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

Model Number N/A

Device Problem Insufficient Information (3190)

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

Event Date 02/25/2022

Event Type  malfunction  

Manufacturer Narrative

This incident has been recorded under (b)(4).Review of the most recent repair record determined the motor speed was unstable, machine head damaged, unit out of calibration, position of control bar incorrect, swivel was old, bearings, screws, and reciprocating arm worn and the motor, sleeve, thickness control shaft, bearings, swivel, widthplate screws, reciprocating arm, head, pin, screw, lever, and ball plunger replaced and resolved the reported issue.Lot identification is necessary for review of device history records, and lot identification was not provided.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

It was reported that the item was sent for repair.Upon evaluation it was noted that the motor speed was inconsistent.No harm or delay was reported as it relates to this event.

Manufacturer Narrative

This incident has been recorded under (b)(6).Updates performed on b3 b4 b5 g3 g6 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 the device was noted to be in need of repair during surgery.There was no impact to the patient and another device was used to complete the procedure.No adverse events were reported as it relates to this event.

• Brand Name: ZIMMER AIR DERMATOME
• 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: 15232484
• MDR Text Key: 304518347
• Report Number: 0001526350-2022-00783
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• 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: 00880100100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2000
• 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