MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER DERMATOME AN

Catalog Number 88710100

Device Problem Loss of Power (1475)

Patient Problem Abrasion (1689)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.

Event Description

It was reported that the surgeon was harvesting a skin graft and the dermatome stopped functioning.Another dermatome was opened and used with the same hose.The new one functioned perfectly.The surgery was delayed 20 minutes and another graft needed to be harvested.No additional consequences were reported.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The device history record for zimmer dermatome an serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The record review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using the machine-repair reports and the repair sites folders on livelink as well as sap to query for all repairs on serial number (b)(4) prior to (b)(6) 2019, the device was noted to have been previously repaired once for visible o-ring on the device reported on 22 february 2019.The reported event was confirmed by the service technician who performed the evaluation and repair.On (b)(6) 2019, it was reported from (b)(6) that a dermatome stopped working during use.The customer returned a zimmer dermatome an serial number (b)(4) for evaluation.Evaluation of the device on 11 june 2019 noted that the planetary gears were frozen up, which prevented the device from operating as intended, but the device was within calibration specifications.The o-ring was also noted to not be sticking out of the device.Repair of the device occurred the same day and involved replacing the planetary and ring gears as well as the carrier on the device.The technician then recalibrated, tested, and verified that the dermatome was functioning as intended, then returned it to the customer without further incident.The dermatome was tested, inspected, and repaired.Reference number (b)(4) on (b)(6) 2019.While the service technician found that the planetary gears were freezing up, which would prevent the dermatome from moving the eccentric shaft and in turn prevent the reciprocating arm from moving, it cannot be determined from the information provided as to what caused the planetary gears to freeze in the first place.Therefore, a specific root cause of the dermatome stopping during use cannot be determined.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: ZIMMER DERMATOME AN
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8627365
• MDR Text Key: 145624550
• Report Number: 0001526350-2019-00375
• 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: 06/18/2019

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 Catalogue Number: 88710100
• Device Lot Number: 64266243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other