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

Model Number N/A

Device Problems Loss of Power (1475); Failure to Power Up (1476); Power Problem (3010)

Patient Problems Abrasion (1689); No Consequences Or Impact To Patient (2199)

Event Date 12/20/2016

Event Type  Injury  

Manufacturer Narrative

The product will not be returning to the manufacturer for evaluation; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.

Event Description

It was reported by the customer that the product lacked power and stopped during the harvest.It blocked during the harvest and had to be restarted.Additional information received january 11, 2017 confirmed the event took place during surgery; however, there was no harm to the patient or operator.There was a 20 minute delay in the procedure and an alternate device was retrieved to complete the surgery.The harvested graft was not useable, and an additional unplanned graft was required.

Manufacturer Narrative

The customer returned an electric dermatome device for evaluation.(b)(4) has previously repaired/evaluated this electric dermatome one time.The last repair was (b)(6) 2015 where the device was returned for preventative maintenance and the cable, switch, reciprocating arm, strain relief and all worn parts were replaced.This is not a related issue.The electric dermatome was manufactured on march 6, 2012, and is over 4 years old at the time this complaint was generated.The previous repair report was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Initial qa inspection of the electric dermatome by (b)(4) on january 4, 2017 revealed that the motor was corroded and the reciprocating arm was worn out.The service technician suggested that the motor, reciprocating arm, lever and the worn parts be replaced.Repair of the electric dermatome was not performed by (b)(4) as the customer cancelled their request.The reported event ¿that the product lacked power and stopped during the harvest.It blocks during the harvest and re-start¿ was confirmed since during the initial inspection by (b)(4) the service technician noted that the motor was corroded and there were multiple worn components.The root cause of the reported event could not be specifically determined, but is most likely related to an issue with the corroded motor.The user could have used improper cleaning/sterilization techniques resulting in the corrosion of the internal components of the device.The ifu states to ¿never immerse the dermatome in any solution.Some solutions will corrode the metal and delicate moving parts and also break down the internal lubricants.¿.

Manufacturer Narrative

The customer returned an electric dermatome device for evaluation.(b)(4) has previously repaired/evaluated this electric dermatome one time.The last repair was november 13, 2015 where the device was returned for preventative maintenance and the cable, switch, reciprocating arm, strain relief and all worn parts were replaced.This is not a related issue.The electric dermatome was manufactured on march 6, 2012, and is over 4 years old at the time this complaint was generated.The previous repair report was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Initial qa inspection of the electric dermatome by (b)(4) on january 10, 2017 revealed that the motor was corroded and the reciprocating arm was worn out.The service technician suggested that the motor, reciprocating arm, lever and the worn parts be replaced.Repair of the electric dermatome was not performed by (b)(4) as the customer cancelled their request.The reported event ¿that the product lacked power and stopped during the harvest.It blocks during the harvest and re-start¿ was confirmed since during the initial inspection by (b)(4) the service technician noted that the motor was corroded and there were multiple worn components.The root cause of the reported event could not be specifically determined, but is most likely related to an issue with the corroded motor.The user could have used improper cleaning/sterilization techniques resulting in the corrosion of the internal components of the device.The ifu states to ¿never immerse the dermatome in any solution.Some solutions will corrode the metal and delicate moving parts and also break down the internal lubricants.¿.

• Brand Name: HANDPIECE, ELECTRIC DERMATOME
• Type of Device: ELECTRIC DERMATOME HANDPIECE
• 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: 6266330
• MDR Text Key: 65377834
• Report Number: 0001526350-2017-00040
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 62008577
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2017
• Initial Date FDA Received: 01/20/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/03/2017; 03/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other