MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. 1.5 TO 1 DERMACARRIER (FOR USE WITH MESHGRAFT II TISSUE EXPANSION SYSTEM); EXPANDER, SURGICAL, SKIN GRAFT

Catalog Number	00219501200
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident has been recorded under (b)(4).Upon completion of investigation a supplemental/final report will be submitted.G2: foreign- japan.E1: telephone- (b)(6) d10: therapy date (b)(6) 2025 quantity (b)(4): item name: 1.5 to 1 dermacarrier, item number: 00219501200, lot: 83371401, sn: n/a.
Event or Problem Description
It was reported that distributor it was noted that there was a foreign substance inside the sterile packaging.No patient involvement.Diligence is complete.
Additional Manufacturer Narrative
This report is being filed to relay final investigation results under (b)(4).The following sections were updated/corrected: b4 b5 d9 g3 g6 h2 h3 h4 h6 h11.Visual examination of the returned product/provided pictures confirmed the label of the package was stained/smeared.Further the package had loose particulates within the sterile packaging (5 total particles ranging from 0.2-0.3 sq.Mm.); therefore, the packaging is not within the acceptance criteria.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The reported event is confirmed.The root cause of the reported issue is attributed to 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.
Event or Problem Description
No additional information related to the event is available.

• Brand Name: 1.5 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: 23403840
• Report Number: 0001526350-2025-01363
• Device Sequence Number: 4916531
• Product Code: FZW
• UDI-Device Identifier: 00889024378773
• UDI-Public: (01)00889024378773(17)300703(10)83371401
• 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): 04/29/2026

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: 00219501200
• Device Lot Number: 83371401
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REFER TO H11
• Patient Sex: Unknown