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

Model Number N/A

Device Problem Failure to Cut (2587)

Patient Problem No Code Available (3191)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).This investigation is still in progress.Once the investigation is complete a final mdr will be submitted.

Event Description

It was reported that during surgery the dermatome was not cutting evenly.There was a delay of 10-20 minutes reported.There was harm to the patient, however it was not described.No additional information is available.

Event Description

No additional event information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).D4 udi: (b)(4).This medwatch is being filed to relay additional information.The device history record (dhr) and previous repair report reviewed noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr and previous repair report review also found that all verifications, inspections and tests were successfully completed.Product review of the air dermatome on (b)(6) 2020 revealed that the calibration was out of specifications at the zero setting only.The motor speed was erratic and the control bar was in the correct position.Repair of the air dermatome was performed by zimmer biomet surgical on (b)(6) 2020 which included replacement of the external e-ring, throttle hinge gasket, spring seal, planetary spacer, motor sleeve, motor, wing washer, and bearing nut.Air dermatome, serial number (b)(6), was then tested and functioned properly.While the returned product investigation confirmed that the air dermatome had an erratic motor, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The device was noted to be functioning as intended after the external e-ring, throttle hinge gasket, spring seal, planetary spacer, motor sleeve, motor, wing washer, and bearing nut were replaced.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: 9665854
• MDR Text Key: 178334749
• Report Number: 0001526350-2020-00121
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00880100100
• Device Lot Number: 63415171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other