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 07/08/2019

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.The device history record and previous repair record for zimmer air dermatome serial number (b)(4) 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 motor on a dermatome was running slow on (b)(6) 2019.The customer returned a zimmer air dermatome serial number (b)(4) to zimmer (b)(4) for evaluation.Evaluation of the device on (b)(6) 2019 noted the machined head was damaged and that there was side play found with the control bar.The dermatome was forwarded to zimmer (b)(4) for further evaluation and repair.Evaluation of the dermatome by zimmer (b)(4) on (b)(6) 2019 noted that the motor ran below motor speed specifications and that the device was out of calibration at all four settings.It was recommended that the motor, reciprocating arm, external e-ring, machine head, an o-ring, a returned 3 in.Width plate, and multiple bearings be replaced.Repair of the dermatome occurred on 30 july 2019 and involved replacing the motor, reciprocating arm, external e-ring, machined head, an o-ring, the returned 3 in.Width plate, and multiple bearings as well as recalibrating the device.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 found that there was a defective motor and reciprocating on the device, which would cause the product to not generate the necessary movement to oscillate the blade so the dermatome can cut efficiently, it cannot be determined from the information provided as to what caused these components to fail.As such, a specific root 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 the motor was running slow.The issue occurred prior to surgery.Subsequently, this caused no patient harm and there was no delay.The surgery was completed using an alternate device and the problem did not cause any impact/damage to graft harvest.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: 9219266
• MDR Text Key: 167764862
• Report Number: 0001526350-2019-00923
• 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: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• 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: 2700200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/1992
• 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