MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME

Catalog Number 00882100100

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the unit would sometimes turn itself off.The issue occurred during surgery.Subsequently this did not caused patient harm and there was no delay.The problem caused damage to graft harvest but the graft harvest was able to be used and no additional unplanned graft harvest was required from the patient.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Udi:(b)(6).Reported issue: on (b)(6) 2019, it was reported that the unit would sometimes turn itself off.The customer returned an electric dermatome device, serial number (b)(6) , for evaluation.Dhr review: 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.Zimmer biomet australia has previously repaired/evaluated electric dermatome serial number (b)(6) two times as documented in the repair reports.The last repair was (b)(6) 2018 where it was reported that the device was sent in for annual service and calibration and the motor, switch, bearings, o-ring, seal, and reciprocating arm were replaced.This is not a related issue.Device evaluations results/investigation findings: product review of the electric dermatome by zimmer biomet taiwan on august 14, 2019 revealed that the calibration was out of specifications at the 0, 20, and 30 settings.The motor speed was within specifications and the control bar was in the correct position.The customer did not return a power supply for evaluation.Repair of the electric dermatome was performed by (b)(6) on (b)(6) , 2019 which included replacement of the motor, switch, bearings, o-ring, seal, reciprocating arm, and external e-ring.Electric dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.Probable cause/root cause: the root cause of the reported event could not be specifically determined with the information that was provided.During the product review by zimmer biomet taiwan it was noted that the device operated within motor speed specifications.It was not noted that the device unintentionally shut itself off.It is unknown with the information that was provided how this occurred.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: 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 for any adverse trends that may warrant further action.

Event Description

No additional event information was received.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8866032
• MDR Text Key: 154021962
• Report Number: 0001526350-2019-00614
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Device Lot Number: 63247422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1