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

Catalog Number 00880100100

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

This complaint is being reported by zimmer biomet as (b)(4).The device was returned to the repair facility; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.Received; not yet evaluated.

Event Description

It was reported that the dermatome started and then stopped.An alternate device was used to finish the surgery.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This complaint is being reported by zimmer biomet as (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected.The device history record (dhr) and previous repair report review noted no related non-conformances, requests for deviation (rfd), change notices (cn) or any other issues with manufacturing.The dhr and previous repair report review found no issues with the device and all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has previously repaired/evaluated air dermatome serial number (b)(4) five times as documented in the repair reports.The last repair was (b)(6) 2011 where it was reported that the device was cutting skin too thick and the ball detent, reciprocating arm, seal and retaining ring, poppet assembly, thickness control lever, bearings, motor and o-ring were replaced.This is not a related issue.Product review of the air dermatome by (b)(6) on (b)(6) 2018 revealed that the device has not been maintained since it was in bad condition.The head, thickness control shaft, control bar, lever, reciprocating arm and motor were all used and worn.The etched lever was the older version.The air hose was also the older version, but there were no leaks on the hose.The motor speed was within specification.The calibration was out of specification.Repair of the air dermatome was performed by (b)(4) on (b)(6) 2018 which included replacement of the ball bearings, o-rings, spring seal, needle bearings, semi-circle bearings, vespel sleeve bearings, poppet housing, poppet spring, throttle hinge, throttle hinge gasket, seal screw, poppet, motor, motor sleeve, thickness control shaft, control bar, aluminum lever, ball plunger, reciprocating arm, etched lever, and screws.Air dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The reported event ¿the device did not work, it started then stopped¿ was non-verifiable since during initial inspection the motor was running within specifications.The root cause of the device not working, it started then stopped, cannot be specifically determined with the provided information since the motor was within specification during product review.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Air dermatome, serial number (b)(4), was repaired, tested and returned to the customer.

• 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7479250
• MDR Text Key: 107497089
• Report Number: 0001526350-2018-00386
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100100
• Device Lot Number: 32903600
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 05/03/2018
• Supplement Dates FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2001
• 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