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

Model Number N/A

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Gas/Air Leak (2946); Appropriate Term/Code Not Available (3191)

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

Event Date 10/11/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - report source - foreign: (b)(4).The product has been returned to zimmer biomet, and the investigation is in process.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Investigation incomplete.

Event Description

It was reported that outside of surgery the unit doesn't work with or without the hose.The device stopped working after being used for many years.The compressed air hose was leaking, but after repair, the dermatome still did not work.No patient involvement or harm.Attempts have been made, but no further event information available at the time of this report.

Event Description

It was reported that outside of surgery the unit doesn't work with or without the hose.The device stopped working after being used for many years.The device was leaking air.No patient involvement or harm.Due diligence is complete and no additional information is available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the unit was not working properly as the motor ran below specifications and the swivel was loose.The needle bearings and reciprocating arm were found to be heavily corroded.The unit was also out of calibration and the control bar was out of position.The motor, sleeve, swivel, needle bearing, and reciprocating arm were replaced and the unit and control bar were recalibrated to resolve the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.It was noted that the device has not been regularly returned for annual pm.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.

• 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: 15751260
• MDR Text Key: 303559112
• Report Number: 0001526350-2022-01096
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• 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: 61919687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2011
• 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
• Treatment: SEE H10.