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

Catalog Number 00882100100

Device Problem Intermittent Loss of Power (4016)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Upon receipt of additional information, the product evaluation and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the device does not operate at full speed.There was no harm to the patient or delay in the procedure as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.D4 - udi# - (b)(4).Dhr review: 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.Device evaluations results/investigation findings: product review of the electric dermatome by zimmer biomet taiwan on december 20, 2019 revealed that the device operated within motor speed specifications but at the lower end.The device was also outside calibration and side to side specifications at all tested thickness settings.Repair of the electric dermatome was performed by zimmer biomet taiwan on december 24, 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 but was at the lower end.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.

Event Description

It was reported that the unit was not operating at full speed.Dermatome handpiece stopped working whilst surgeon was harvesting skin graft.No other handpieces were available as they were out for repair.They were unable to complete surgery.There was harm to the patient as an additional surgery was needed.Surgical time was delayed 16-30 minutes while patient was under anesthesia.Additional surgery was required.No additional consequences have been reported as a result of this malfunction.

• 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: 9394723
• MDR Text Key: 189632973
• Report Number: 0001526350-2019-01086
• 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: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention