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

Catalog Number 00880100100

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed as an initial / final report based on information discovered during the device evaluation.Udi# - (b)(4).Dhr review: 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.Technical review and physical evaluation: during evaluation of the device it was determined that the rpm was out of specification.The calibration was out of specification at several readings.The motor, bearing pack, o-ring, seal, reciprocating arm, were defective and needed to be replaced.The customer returned the device serial number (b)(4) for evaluation.The technician then replaced the defective components, recalibrated the device and verified that it was functioning as intended.The device was then returned to the customer without further incident.The device was tested, inspected, and repaired.Probable/root cause: while this device was brought in for preventative maintenance, it was noted that it required repair for additional defective components.It is unknown with the information that was provided what led to the defectiveness of the replaced components.Therefore, based on the information that was provided the root cause of the reported event could not be specifically determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: based on the information provided, this investigation determined that there is no need for further action at this time.This complaint will be tracked and trended for any adverse trends that may require additional actions.

Event Description

It was reported that the product was sent for pm, later it was noticed that it required repair.During evaluation of the device it was determined that the rpm was out of specification.No adverse events were reported as a result of this malfunction.

• 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: 9403108
• MDR Text Key: 197748274
• Report Number: 0001526350-2019-01100
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/03/2019

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: 63415160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1