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

Catalog Number 00880100100

Device Problem Calibration Problem (2890)

Patient Problem Laceration(s) (1946)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental medwatch will be filed.

Event Description

It has been reported that the device was taking thick grafts.Surgery time was not effected.No additional graft was taken.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b1, b4, b5, d4, d10, g4, g7, h2, h3, h6 and h10.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 by zimmer biomet taiwan on november 4, 2019 revealed that the motor speed was below specifications.The calibration was out of specifications at all settings and the control bar was in the correct position.The customer width plates were not returned for evaluation.Repair of the air dermatome was performed by zimmer biomet taiwan on november 6, 2019 which included replacement of the motor, bearings, o-ring, seal, reciprocating arm, external e-ring, machined head, and throttle hinge gasket.Air dermatome, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.While the returned product investigation confirmed that the air dermatome was out of calibration at all settings, 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 unit was recalibrated and the motor, bearings, o-ring, seal, reciprocating arm, external e-ring, machined head, and throttle hinge gasket were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information.

• 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: 9328029
• MDR Text Key: 166557150
• Report Number: 0001526350-2019-01013
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• 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: 62682589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other