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

Catalog Number 00880100100

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

The event recorded by zimmer biomet under (b)(4).Customer has indicated that product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that the unit had missing screws.The event occurred during testing.There was no harm and delay in the event.No patient involvement.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

The device history record and previous repair record for zimmer air dermatome serial number (b)(6) was reviewed noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The record reviews found no issues with the device and all verifications, inspections, and tests were successfully completed.Using the machine-repair reports and the repair sites folders on livelink as well as sap to query for all repairs on serial number (b)(6) prior to 2 may 2019, the device was noted to have been previously repaired once for the motor being dead and the device being out of calibration and corroded on 8 july 2009.On 2 may 2019, it was reported from university of california irvine medical center that a dermatome was missing screws.The customer was asked to return a zimmer air dermatome serial number (b)(6) and was quoted for service on the device; however, at the time of the investigation, the customer has yet to accept the quote and the device had not been noted to have been returned for service.As such, no evaluation or repair can be reviewed as part of the investigation.The device was not returned for evaluation or repair.As such, the root cause of the dermatome missing a screw cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined that there are no further actions needed at this time.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may warrant further action.Requested but not retunred.

• 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: 8592492
• MDR Text Key: 145251578
• Report Number: 0001526350-2019-00350
• 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: consumer,user facility
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• 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: 60423395
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1