MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 1.5 TO 1 DERMACARRIER; EXPANDER, SURGICAL, SKIN GRAFT

Catalog Number	00219501200
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial / final report based on information discovered during the device evaluation.Visual inspection determined there is no seal on the right end of the package.The rest of the package is sealed.There is no sign of glue present on the right end of the seal.The dermacarrier was missing from the package.Review of the device history record identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to manufacturing issue.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.G2: foreign : japan.
Event or Problem Description
It was reported that during incoming inspection, there was no product in the sterile package.There was no patient involvement.During device evaluation, it was discovered that the visual inspection determined there is no seal on the right end of the package.Due diligence is complete, there is no additional information available.

• Brand Name: 1.5 TO 1 DERMACARRIER
• 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: 22685664
• Report Number: 0001526350-2025-01037
• Device Sequence Number: 8937352
• Product Code: FZW
• UDI-Device Identifier: 00889024378773
• UDI-Public: (01)00889024378773(17)291205(10)79956813
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2025

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 Catalogue Number: 00219501200
• Device Lot Number: 79956813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown