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

Catalog Number 00880100100

Device Problem Failure to Cut (2587)

Patient Problems Abrasion (1689); No Code Available (3191)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been returned to the repair center for evaluation and investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

It was reported that the surgeon claimed that dermatome takes too thin skin graft.An additional graft was required; a delay of 40 minutes was reported in order to obtain a new dermatome and to take an additional graft.No additional patient consequences were reported.

Event Description

No additional event information available.

Manufacturer Narrative

The device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Medicrea/flextronics has not previously repaired/evaluated air dermatome serial number (b)(6) as documented in the repair reports in livelink.On may 14, 2019, it was reported that some surgeons claimed that dermatome takes too thin skin graft.(maybe flextronics could check that the thickness knob is not too slack which could cause that it can move during use).An additional graft was required; a delay of 40 minutes was reported in order to obtain a new dermatome and to take an additional graft.Follow up confirmed only one surgeon and one event- it was a new (unexperienced) surgeon.The customer returned an air dermatome device, serial number (b)(6), for evaluation.Product review of the air dermatome by flextronics on may 31, 2019 revealed that the needle bearing was defective and the eccentric shaft was damaged.The external e-rings were corroded.The calibration was within specifications and the control bar was in the correct position.The motor speed was below specification.The thickness control lever was loose and the ball plunger was damaged.The customer hose and width plates were not returned for evaluation.Repair of the air dermatome was performed by flextronics on june 12, 2019 which included replacement of the semi-circle shaft bearings, motor, ball plunger, spring seal, vessel bearings, external e-ring, internal retaining ring, eccentric shaft assembly, die cast lever, motor sleeve, and needle bearing.Air dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Rma number (b)(4).Although the reported event was confirmed during inspection of the device, and the device was found to be functioning as intended after the repair was completed, it cannot be determined from the information provided what caused the reported event.Therefore, the root cause could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: ZIMMER AIR DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8675840
• MDR Text Key: 147234178
• Report Number: 0001526350-2019-00437
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00880100100
• Device Lot Number: 60275786
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/23/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention