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

Model Number N/A

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Abrasion (1689)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It has been reported there was a calibration issue, and the grafts were too thick/shred.The graft had a swiss cheese look.They took 3 total grafts, and of the 3, 2 were able to be used.It is unknown if the 3rd was able to be used.There was harm to the patient.No additional patient consequences were reported as a result of this malfunction.

Event Description

No additional event information.

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).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.On december 5, 2019, it was reported that there was a calibration issue and the grafts were too thick/shred.It shredded the graft and was giving the graft a "swiss cheese look".They took three total grafts and two were able to be used.The customer returned a dermatome an device, serial number (b)(6), for evaluation.The customer also returned a hose and 1"/2"/3"/4" width plates, for evaluation.Product review of the dermatome an on december 20, 2019 revealed that control bar was not in the correct position.The calibration and motor speed were both within specifications.Repair of the dermatome an was performed by zimmer biomet surgical on december 20, 2019 which included replacement of the ball plunger, thickness control lever, vespel bearings, and semi-circle bearings.Dermatome an, serial number (b)(6), was then tested and functioned properly.It was repaired, inspected and tested.While the returned product investigation confirmed that the dermatome an had the control bar in the wrong position, it cannot be determined from the information provided what actually caused the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The device was noted to be functioning as intended after the ball plunger, thickness control lever, vespel bearings, and semi-circle bearings were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: DERMATOME AN HANDPIECE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 9519978
• MDR Text Key: 175252840
• Report Number: 0001526350-2019-01187
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• 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: 88710100
• Device Lot Number: 64371029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other