MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC PROPHECY ANT MOUNTING PLATE INBONE TOTAL ANKLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	PTA00040
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported by the customer that a k-wire got stuck in pta00040 during a pre-surgery walkthrough with surgeon.The instrument was not used on a patient.Images shows the broken k-wire in one of the holes of the instrument.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and a pin was confirmed to be broken off in one of the pin through holes.Examination of the returned device finds the instrument exhibits wear and tear indicative of a reusable instrument that has been used over the years.Inside one of the pin holes is a pin that has been jammed and subsequently sheared off due to the jam.Examination of the fracture surface of the pin finds it to be consistent with a torsional overload fracture following jamming of the pin in the through hole.Dimensional inspection: a dimensional inspection of the affected pin hole was not possible since the pin was cold welded inside and unable to be removed.However, a 2.4mm pin was used in the other hole and demonstrated the ability of the pin to move easily through the hole.Indicating that hole was manufactured to specification.This is a known issue from through-holes experiencing wear from bending/insertion/extraction of pins/k-wires during surgery.This is most likely due to galling between components from multiple uses and/or misuse.Based on investigation, the root cause was attributed to a user related issue.The event was caused by bending or insertion of the wire at an angle during use resulting in jamming of the pin.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported by the customer that a k-wire got stuck in pta00040 during a pre-surgery walkthrough with surgeon.The instrument was not used on a patient.Images shows the broken k-wire in one of the holes of the instrument.

• Brand Name: PROPHECY ANT MOUNTING PLATE INBONE TOTAL ANKLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21838663
• Report Number: 3010667733-2025-00461
• Device Sequence Number: 20858419
• Product Code: LXH
• UDI-Device Identifier: 00889797051989
• UDI-Public: 00889797051989
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: Health Professional
• Device Catalogue Number: PTA00040
• Device Lot Number: 1322883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2014
• 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 Number: 1
• Patient Sex: Unknown