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

Catalog Number 00882100100

Device Problem Loss of Power (1475)

Patient Problem Laceration(s) (1946)

Event Date 02/21/2019

Event Type  Injury  

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

Sound of dermatome was like it would work only with half effectivity and then it stopped working totally.They got only one little piece of skingraft and they had to take more graft from different area with another dermatome.

Manufacturer Narrative

This event was recorded by zimmer biomet under (b)(4).D4, udi #: (b)(4).Conclusion summary: on (b)(6), 2019, it was reported that the dermatome sounded like it would only work half effectively and then it stopped working completely.The customer returned an electric dermatome device, serial number (b)(6), 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.Medicrea/flextronics has not previously repaired/evaluated electric dermatome serial number (b)(6) as documented in the repair reports in livelink.Product review of the electric dermatome by flextronics on april 8, 2019 revealed that the motor was defective.The control bar position was also not correct and the soldering was defective.Repair of the electric dermatome was performed by flextronics on may 17, 2019 which included replacement of the motor, repositioned the control bar and resoldered the defective soldering.Electric dermatome, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.The reported event was confirmed since during the product review by flextronics it was noted that the motor was defective.The root cause of the reported event could not be specifically determined with the information that was provided.During the product review by flextronics it was noted that the motor was defective.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.

• 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: 8495113
• MDR Text Key: 141314550
• Report Number: 0001526350-2019-00225
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00882100100
• Device Lot Number: 63526314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR