MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. OXF PKR CMTLESS SAW BLADES 3PK; Blade, Saw, General & Plastic Surgery, Surgical

Catalog Number	113769
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under cmp-(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 unit has a sterilization of seal issue that needs to be reviewed.There was no patient impact or delay.Due diligence is complete and there is no additional information available.

• Brand Name: OXF PKR CMTLESS SAW BLADES 3PK
• Common Device Name: Blade, Saw, General & Plastic Surgery, Surgical
• 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: 24606739
• Report Number: 0001526350-2026-00284
• Device Sequence Number: 10372552
• Product Code: GFA
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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 Number: 113769
• Device Lot Number: 467412
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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: ANAT BRG RT SM SIZE3PMA.LOT: 67221166.; SYN OX CL 3 PK ST HUB.LOT: 492354.; TWIN PEG CMNTLSFMRLSM.LOT: 67236414.; UNI CMNTLS TIBSZSIZEA.LOT: 67107734.
• Patient Sex: Unknown