MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER SKIN GRAFT MESHER; EXPANDER, SURGICAL, SKIN GRAFT

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4) product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the zimmer skin graft mesher had loose pins and the mesher gave an incomplete mesh on very thin skin during meshing of previously recovered cadaveric donor skin.No adverse events were reported 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.On (b)(6) 2018, it was reported the unit had loose pins.The customer returned a skin graft mesher device, serial number (b)(4), for evaluation.Clinical follow up indicated that the mesher gave an incomplete mesh on very thin skin.The customer also returned a 1.5:1 ratio cutter, serial number (b)(4), and a 2:1 ratio cutter, serial number (b)(4) for evaluation.The device history record (dhr) and previous repair report of skin graft mesher device, serial number (b)(4) reviewed noted no related non-conformances, requests for deviation (rfd), change notices (cn) or any other issues with manufacturing.The dhr and previous repair report review found no issues with the device and all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has previously repaired/evaluated skin graft mesher serial number (b)(4) five times as documented in the repair reports in livelink.The last repair was february 27, 2018 where it was reported that the device was producing an incomplete mesh and the roller, worn bushings, worn side plates, gear, and screws were replaced.This is not a related issue.The device history record (dhr) and previous repair report skin graft mesher 1.5:1 ratio cutter, serial number (b)(4), reviewed noted no related non-conformances, requests for deviation (rfd), change notices (cn) or any other issues with manufacturing.The dhr and previous repair report review found no issues with the device and all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has previously repaired/evaluated skin graft mesher 1.5:1 ratio cutter, serial number (b)(4), as documented in the repair reports in livelink.The last repair was february 27, 2018 where it was reported that the device sent skin graft mesher serial number (b)(4) and the roller, worn bushings and gear were replaced.The device history record (dhr) and previous repair report of 2:1 ratio cutter, serial number (b)(4), reviewed noted no related non-conformances, requests for deviation (rfd), change notices (cn) or any other issues with manufacturing.The dhr and previous repair report review found no issues with the device and all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has previously repaired/evaluated skin graft mesher 2:1 ratio cutter, serial number (b)(4) as documented in the repair reports in livelink.The last repair was february 27, 2018 where it was reported that the device sent skin graft mesher serial number (b)(4) and the roller, worn bushings and gear were replaced.Initial qa inspection of the skin graft mesher on april 9, 2018 revealed that the right side plate was damaged where the sliding pin slides into it.The sliding pins, shoulder bolts, and comb were all damaged on the device.The pretest could not be performed due to the damaged side plate.The 1.5:1 ratio cutter, serial number (b)(4) produced a passing sample mesh.The 2:1 ratio cutter, serial number (b)(4) failed to produce a passing sample mesh and was deemed non-repairable.Repair of the skin graft mesher was performed by zimmer biomet surgical on april 9, 2018 which included replacement of the bushings, side plates, comb, ball detents, and shoulder bolts.Skin graft mesher, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The reported event was confirmed since during initial inspection it was noted that the right side plate was damaged where the sliding pin slides into it.It was also noted that the 2:1 ratio cutter, serial number (b)(4) failed to produce a passing sample mesh and comb was damaged.The root cause that the unit had loose pins was due to the damaged right side plate where the sliding pin slides into it which caused the pins to set loose.While during initial inspection it was noted that the 2:1 ratio cutter, serial number (b)(4) both failed zimmer biomet test cut criteria, it is unknown how this cutter damaged.Therefore, a root cause of the device produced incomplete mesh cannot be specifically determined with the provided information.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.No further conclusions can be drawn from the complaint history review that warrants further action.

• Brand Name: ZIMMER SKIN GRAFT MESHER
• Type of Device: EXPANDER, SURGICAL, SKIN GRAFT
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 7409743
• MDR Text Key: 105155167
• Report Number: 0001526350-2018-00309
• Device Sequence Number: 1
• Product Code: FZW
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00770100000
• Device Lot Number: 63138572
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1