MAUDE Adverse Event Report: Stryker Orthopaedics-Mahwah D-M 1.6MM BEADED CABLE SET SS; Plate, Fixation, Bone

Catalog Number	3704-0-040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: left hip.Patient revised as one of the cable snapped.Surgeon removed all cables and cable plate.Surgeon attempted to re-implant a new, longer cable plate but changed his mind during the case.No other information available due to hospital policy.

• Brand Name: D-M 1.6MM BEADED CABLE SET SS
• Common Device Name: Plate, Fixation, Bone
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50101874
• Report Number: 0002249697-2026-00660
• Device Sequence Number: 21345025
• Product Code: HRS
• UDI-Device Identifier: 07613327036336
• UDI-Public: 07613327036336
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K240418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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: 3704-0-040
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 87 YR
• Patient Sex: Female