MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 5 ACCOLADE II BROACH; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number	1020-5205
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Distributor report: "the attachment pole of the accolade ii rasp no.5 broke off during impaction.The rasp was removed and another set was opened.".
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an accolade broach was reported.The event was confirmed via inspection of the returned device.Method & results: -device evaluation and results: visual inspection of the returned device indicated that the connection post of the broach is fractured at or near thinnest point of the ¿v.¿ the device otherwise appears well-used based on the damage visible on all other areas of the post and proximal surfaces.Material analysis: not performed as visual inspection provided no indication that the event was a result of a material integrity issue.The device overall appears severely worn as significant mechanical damage is visible on the proximal surfaces of the device.Material analyses have been performed on previously returned devices indicating fracture in overload and device material consistent with the product drawing.If further information becomes available additional testing will be performed on this device.-clinician review: no medical records were received for review with a clinical consultant.-device history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: it was repoted that the device's post broke during impaction visual inspection of the returned device indicated that the connection post of the broach is fractured at or near thinnest point of the ¿v.¿ the device otherwise appears well-used based on the damage visible on all other areas of the post and proximal surfaces.Material analysis: not performed as visual inspection provided no indication that the event was a result of a material integrity issue.The device overall appears severely worn as significant mechanical damage is visible on the proximal surfaces of the device.Material analyses have been performed on previously returned devices indicating fracture in overload and device material consistent with the product drawing.If further information becomes available additional testing will be performed on this device.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.

• Brand Name: SIZE 5 ACCOLADE II BROACH
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22586282
• Report Number: 0002249697-2025-00719
• Device Sequence Number: 9393063
• Product Code: KWL
• UDI-Device Identifier: 07613327252705
• UDI-Public: 07613327252705
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 1020-5205
• Device Lot Number: 139596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2017
• 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