MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. MESHGRAFT II INSTRUMENT ONLY; SKIN GRAFT MESHER

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Failure to Cut (2587); Patient Device Interaction Problem (4001)

Patient Problems Abrasion (1689); Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2023

Event Type  Injury  

Event Description

It was reported that during surgery, the unit did not work properly.The upper roller had symptoms of loosening.The surgeon was not able to increase skin graft.There was no patient harm/injury.There was no medical intervention or surgical delay.Due diligence is in progress; to date no additional information has been received.

Manufacturer Narrative

An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.G2: foreign: poland e1: telephone: (b)(6).

Manufacturer Narrative

An investigation into the reported event has been initiated under cmp-(b)(4).The following sections have been corrected/updated: b1, b2, b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, h8, and h10.Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.

Event Description

It was reported that during surgery on the unit did not work properly.The upper roller had symptoms of loosening.The surgeon was not able to increase skin graft.The head was loose and therefore did not cut the skin.The skin could not be reticulated.There was no surgical delay reported.Another device was not used to complete the surgery, the procedure was completed manually.An additional unplanned skin graft needed in order to complete the surgery.Due diligence is complete, no further information is available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the device failed the test mesh during device evaluation as the cutter was damaged and the ratchet would not turn at all as the spring was corroded.Additionally, the roller was discolored, and the unit was out of calibration.Per customer request, the unit was returned to the customer unrepaired.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

There is no additional information available.

• Brand Name: MESHGRAFT II INSTRUMENT ONLY
• Type of Device: SKIN GRAFT MESHER
• 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: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17138875
• MDR Text Key: 317494660
• Report Number: 0001526350-2023-00579
• Device Sequence Number: 1
• Product Code: FZW
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• 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: 00219500100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Prefer Not To Disclose