MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II BROACH; Screw, Fixation, Bone

Catalog Number	1020-5206
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been similar event(s) for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following information was provided: on monday, (b)(6) 2026 during a total hip replacement surgery, a curette from the accolade stem instrument broke during the procedure.This curette is used to prepare the intramedullary canal prior to implanting the accolade stem and is also left in place as a trial stem.During the procedure, the metal segment where the extractor is inserted broke, preventing its normal removal from the patient.The surgeon had to perform a femoral osteotomy to remove the stem, followed by a wire fixation, which resulted in a longer surgical time and an additional, unplanned procedure for the patient.The patient indicated that he will be taking legal action to the clinic and with stryker.Procedure identification: left hip replacement with trident1 acetabular cup and accolade stem.

• Brand Name: SIZE 6 ACCOLADE II BROACH
• Common Device Name: Screw, Fixation, Bone
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 24870190
• Report Number: 0002249697-2026-00286
• Device Sequence Number: 10020058
• Product Code: HWC
• UDI-Device Identifier: 07613327252729
• UDI-Public: 07613327252729
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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 Expiration Date: 01/31/2020
• Device Catalogue Number: 1020-5206
• Device Lot Number: SMM9N17
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2015
• 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: Required Intervention; Hospitalization
• Patient Age: 24 YR
• Patient Sex: Male