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

Model Number N/A

Device Problem Calibration Problem (2890)

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

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the rpms were in specification, the control bar was in the correct position, the calibration is in at all readings, the torque for the thickness control lever was loose and the ball plunger in the thickness control lever was damaged.The thickness control lever, bar, and shaft were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is confirmed.G2, country event occurred in: canada.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 unit was sent in for calibration; it wasn¿t used in or during surgery.Only calibration was needed.No event date is available as the unit was not involved in an event.Also, there was no harm or injury to patient as there was no patient involvement.After evaluation of the retuned product, it was observed that the device's torque for the thickness control lever was loose.Due diligence is complete.No additional information is available.No adverse event reported.

• 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: 18160957
• MDR Text Key: 328415844
• Report Number: 0001526350-2023-01520
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• 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: 61897028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2011
• 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 Sex: Prefer Not To Disclose