MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 3 TO 1 DERMACARRIER (FOR USE WITH MESHGRAFT II TISSUE EXPANSION SYSTEM); EXPANDER, SURGICAL, SKIN GRAFT

Model Number	N/A
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.G2: foreign country - uk.
Event or Problem Description
It was reported during surgery that the dermacarrier is not expanding the skin properly when put through the mesher.Compared the carrier with another box and the grooves were noted to be different.There is no harm or delay reported, due diligence is in progress.
Event or Problem Description
There is no additional information available.
Additional Manufacturer Narrative
Following sections were updated or corrected : a3, b4, b5, d2, d4, d9, g1, g3, g6, e3, e1, d10, h1, h2, h3, h4, h6, h11, h10, h8 the angle measurement of the carrier was approximately 9 degrees 51 minutes when measured, which is within specification for a 3:1 carrier according to the product drawing.No problem found.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.The event is not 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.

• Brand Name: 3 TO 1 DERMACARRIER (FOR USE WITH MESHGRAFT II TISSUE EXPANSION SYSTEM)
• Common Device Name: EXPANDER, SURGICAL, SKIN GRAFT
• 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: 18616355
• Report Number: 0001526350-2024-00171
• Device Sequence Number: 2368919
• Product Code: FZW
• UDI-Device Identifier: 00889024372566
• UDI-Public: (01)00889024372566(17)260103(10)64980604
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2026
• Device Model Number: N/A
• Device Catalogue Number: 00219501300
• Device Lot Number: 64980604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 00219501300 3 TO 1 DERMACARRIER LOT 64980604.; 00219501300 3 TO 1 DERMACARRIER LOT 64980604.; 00219501300 3 TO 1 DERMACARRIER LOT 64980604.; 00219501300 3 TO 1 DERMACARRIER LOT 64980604.; 00219501300 3 TO 1 DERMACARRIER LOT 64980604.
• Patient Sex: Prefer Not To Disclose