MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC SAW BLADE STRYKER UNIV WIDE TOTAL ANKLE .500 IN; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	200138108S
Medical Device Problem Codes	Residue After Decontamination (2325); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that "upon opening this saw blade, there was adhesive tape on the blade.Since we doubted the sterility and since the tape was not removable, i decided to consider this saw blade unusable." the event was identified in the or while the patient was under anesthesia and the surgery was completed successfully.
Additional Manufacturer Narrative
Correction to d5 (operator of device) from lay user/patient to other (sales rep) and h3(device evaluated by mfg).The reported event could be confirmed based on assessment of returned device by gqo.A visual inspection of the returned device shows a plastic piece which appears to be shrink wrap sticking on the saw blade surface.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Gqo analyzed the returned product and confirmed that there was plastic shrink wrap stuck on the saw blade surface.However, with the information given, they were unable to determine the reason and cause of how the piece of shrink wrap reached there.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that "upon opening this saw blade, there was adhesive tape on the blade.Since we doubted the sterility and since the tape was not removable, i decided to consider this saw blade unusable." the event was identified in the or while the patient was under anesthesia and the surgery was completed successfully.

• Brand Name: SAW BLADE STRYKER UNIV WIDE TOTAL ANKLE .500 IN
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22637168
• Report Number: 3010667733-2025-00871
• Device Sequence Number: 21223457
• Product Code: GFA
• UDI-Device Identifier: 00889797057219
• UDI-Public: (01)00889797057219(11)240607(17)320607(10)1777786
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: Other
• Device Catalogue Number: 200138108S
• Device Lot Number: 1777786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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