MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 3 ACCOLADE II BROACH; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	1020-5203
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The "peg" on the femoral rasp is broken off.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : device not returned.
Event or Problem Description
The "peg" on the femoral rasp is broken off.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an accolade rasp was reported.The event was confirmed through evaluation of the returned device.Method & results: product evaluation and results: visual inspection: 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.Dimensional inspection: dimensional inspection was not performed as dimensional aspects are not in question.Functional inspection: functional inspection was not performed as functional aspects are not in question.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, including the non-fracture surfaces of the connection post.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.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: visual inspection: 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.Dimensional inspection: dimensional inspection was not performed as dimensional aspects are not in question.Functional inspection: functional inspection was not performed as functional aspects are not in question.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, including the non-fracture surfaces of the connection post.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 is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIZE 3 ACCOLADE II BROACH
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17705590
• Report Number: 0002249697-2023-01000
• Device Sequence Number: 17933490
• Product Code: LPH
• UDI-Device Identifier: 07613327252613
• UDI-Public: 07613327252613
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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: 1020-5203
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2014
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown