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

Catalog Number 00882100100

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the motor was not running smooth and not enough power.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).Udi: (b)(4).On march 26, 2019, it was reported that the motor was not running smooth and did not have enough power.The customer returned an electric dermatome device, serial number 207110, for evaluation.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.Zimmer biomet australia/zimmer biomet taiwan has not previously repaired/evaluated electric dermatome serial number 207110.Product review of the electric dermatome by zimmer biomet taiwan on april 17, 2019 revealed that the device operated within motor speed specifications but was outside calibration and side to side specifications.Repair of the electric dermatome was performed by zimmer biomet taiwan on april 22, 2019 which included replacement of the motor, handpiece switch, bearing pack, 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.The reported event was non-verifiable since during the product review by zimmer biomet taiwan it was noted that the device operated within motor speed specifications.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 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.

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: 8543929
• MDR Text Key: 142897397
• Report Number: 0001526350-2019-00280
• 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: 07/18/2019

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: 00882100100
• Device Lot Number: 63760491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 07/18/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1