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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. ZIMMER SKIN GRAFT MESHER; EXPANDER, SURGICAL, SKIN GRAFT

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ZIMMER SURGICAL, INC. ZIMMER SKIN GRAFT MESHER; EXPANDER, SURGICAL, SKIN GRAFT Back to Search Results
Catalog Number 00770100000
Medical Device Problem Code Failure to Advance (2524)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 02/25/2026
Type of Reportable Event Malfunction
Additional 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.
 
Event or Problem Description
It was reported that during surgery the device is not ratcheting and the carrier is not going all the way through the mesher.It is unknown if there was patient impact or delay.Due diligence is in process and there is no additional information available.
 
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Brand Name
ZIMMER SKIN GRAFT MESHER
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 Key24662341
Report Number0001526350-2026-00305
Device Sequence Number9198320
Product Code FZW
UDI-Device Identifier00889024375390
UDI-Public(01)00889024375390(11)240426
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Company Representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/23/2026
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
Operator of Device Health Professional
Device Catalogue Number00770100000
Device Lot NumberUNKNOWN
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/25/2026
Initial Report FDA Received Date03/23/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured04/26/2024
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 Reuse
Patient Sequence Number1
Patient SexUnknown
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