MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER® S.G. CARRIER 16 IN LENGTH; EXPANDER, SURGICAL, SKIN GRAFT

Catalog Number	00771600010
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident was recorded under (b)(4).Once investigation is completed a supplemental/final report will be submitted.G2: foreign: japan e1: telephone: (b)(6).
Event or Problem Description
It was reported that during incoming inspection a hair like substance was found in the package of two devices.No harm or surgical delay occurred as there was no patient involvement.Due diligence is complete.
Event or Problem Description
No additional event information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information related to final investigation.The following sections were updated: b4 b5 d9 g3 g6 h2 h3 h4 h11.Complaint can be confirmed through the returned product analysis.Visual inspection confirmed there was 1 carrier with a large plastic debris sealed in the package as well as 2 carriers with hair-like debris sealed inside the packages.The hair in image 1042 from (b)(4) looks approximately between 2mm and 3mm squared.The hair in image 1043 from (b)(4) looks approximately between 0.8mm and 1mm squared.Per zpc 8.400 this is not within packaging specifications.The device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause has been identified as a manufacturing issue.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: ZIMMER® S.G. CARRIER 16 IN LENGTH
• 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: 22519933
• Report Number: 0001526350-2025-00946
• Device Sequence Number: 9231445
• Product Code: FZW
• UDI-Device Identifier: 00889024380172
• UDI-Public: (01)00889024380172(17)300507(10)81312817
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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
• Device Catalogue Number: 00771600010
• Device Lot Number: 81312817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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