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

Model Number N/A

Device Problem Intermittent Loss of Power (4016)

Patient Problem Abrasion (1689)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.Report source - foreign - (b)(6).

Event Description

It was reported that the unit stopped running mid skin graft procedure.The theatre staff and plastics pho tried swapping power units, not hand piece, without being able to successfully run the hand piece again.The procedure was completed with available graft taken prior to the break down.The procedure had to be terminated prematurely, with only partial graft possible due to failure.The wounds were vacuum dressed the patient woken to be told procedure hadn't been completed as planned and would need to be completed at a later time and date.A second procedure has been arranged to complete the skin grafting.There was a 30 minute surgical delay reported.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated: b2, b4, d4, d10, g4, g7, h2, h3, h4, h6, h8.H10.D4 - udi #: (b)(4).On(b)(6)2019 , it was reported that the unit stopped running mid skin graft procedure.The customer returned an electric dermatome device, serial number (b)(6) , for evaluation.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.Product review of the electric dermatome by zimmer biomet taiwan on (b)(6)2020 revealed that the device did not operate and was outside calibration specifications.Repair of the electric dermatome was performed by zimmer biomet taiwan on (b)(6)2020 which included replacement of the motor, 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 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 did not operate.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.Review of the information provided during the investigation determined that there are no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional event information.

• 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: 9363605
• MDR Text Key: 167761073
• Report Number: 0001526350-2019-01062
• 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: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00882100100
• Device Lot Number: 63704661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other