MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DALL MILES VIT 2.0MM CABLE; CERCLAGE, FIXATION

Catalog Number	6704-8-240
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision procedure of proximal femur gmrs.Multiple previous revisions; cables implanted during procedure (b)(6) 2023.No details available of procedures prior to this date.Dall miles cable had snapped and frayed in the patient.Cables and cable grip removed and frayed metal removed under x ray guidance.No new implants were put in.All of the items are still in patient except for the cables and cable grip which were removed during this event.
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

• Brand Name: DALL MILES VIT 2.0MM CABLE
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21263920
• Report Number: 0002249697-2025-00131
• Device Sequence Number: 9413029
• Product Code: JDQ
• UDI-Device Identifier: 07613327036497
• UDI-Public: 07613327036497
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K945294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6704-8-240
• Device Lot Number: 99509605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Unknown