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

Catalog Number 00880100100

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded with zimmer biomet under cmp-(b)(4).This medwatch is being filed as an initial / final report based on information discovered during the device evaluation.(b)(6).The device history record and previous repair record for zimmer air dermatome serial number 111457 was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with the device.The record reviews found no issues with the device and all verifications, inspections, and tests were successfully completed.The reported event was confirmed by the service technician who performed the evaluation and repair.On (b)(6) 2019, it was reported that the pin on a dermatome was missing on (b)(6) 2019.The customer returned a zimmer air dermatome serial number (b)(4) for evaluation.Evaluation of the device at zimmer (b)(4) on (b)(6) 2019 noted that a pin was missing from the swivel.The device was forwarded to zimmer (b)(4) for evaluation.Evaluation of the dermatome by zimmer (b)(4) on (b)(6) 2019 found that the device was running within motor speed specifications, but was out of calibration at all four settings.Further review of the dermatome found that it was missing the pin and had a motor that didn't run smoothly and defective bearings, o-ring, seal, reciprocating arm, and external e-ring.Repair of the dermatome occurred on (b)(6) 2019 and involved replacing the motor, multiples bearings, the o-ring, a seal, the reciprocating arm, the missing pin, and an external e-ring.The technician then tested and verified that the device was functioning as intended, then returned the device to the customer without further incident.The device was tested, inspected, and repaired.While the service technician does find that the pin had fallen out of the device, it is unknown from the information provided as to how the pin could have fallen out of the device.As such, a specific cause of the reported event 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.

Event Description

It was reported that air dermatome pin on hand piece was missing.Device investigation found the motor did not run smoothly.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: 9634292
• MDR Text Key: 195282647
• Report Number: 0001526350-2020-00098
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2020

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: 62682589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1