MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II BROACH; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	1020-5206
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.H3 other text: device not returned.
Event or Problem Description
During broaching for a tha using the accolade broaches, the surgeon reached the desired size broach of 6- when attempting to remove the size 6 broach from the femoral canal the stub on top snapped resulting in the broach being stuck in the femoral canal.The surgeon made attempts to remove the broach but ultimately had to perform an eto and then use dal miles cables and changed femoral implant system to securfit.
Event or Problem Description
During broaching for a tha using the accolade broaches, the surgeon reached the desired size broach of 6- when attempting to remove the size 6 broach from the femoral canal the stub on top snapped resulting in the broach being stuck in the femoral canal.The surgeon made attempts to remove the broach but ultimately had to perform an eto and then use dal miles cables and changed femoral implant system to securfit.Additional information provided 5/12/2023: estimated surgical delay of 1 hour.The device was completely removed from the patient.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an accolade rasp was reported.The event was confirmed via provided photographs of the device.Method & results: product evaluation and results: the reported device was not returned; however a photograph was provided for review.The photograph shows that the post of the broach has fractured at the narrowest point of the "v" shaped locking mechanism.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the broach fractured during surgery and the patient had to undergo an extended trochanteric osteotomy to remove the device from the femur.The reported device was not returned; however a photograph was provided for review.The photograph shows that the post of the broach has fractured at the narrowest point of the "v" shaped locking mechanism.Further information such as return of the device is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an accolade rasp was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the post of the broach has fractured.The device otherwise appears well-used based on the damage visible on all other areas of the post and proximal surfaces.Material analysis: material analyses have been performed on previously returned devices indicating fracture in overload.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: it was reported that the broach fractured during surgery and the patient had to undergo an extended trochanteric osteotomy to remove the device from the femur.Visual inspection of the returned device indicated that the post of the broach has fractured.The device otherwise appears well-used based on the damage visible on all other areas of the post and proximal surfaces.Material analyses have been performed on previously returned devices indicating fracture in overload.The life of the instruments depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.Instruments should be examined for wear or damage by physicians and staff in operating centers prior to surgery.Any faulty instruments must be replaced prior to any surgical procedure.If the device had met the end of its useful life prior to surgery, this certainly would have contributed to the reported fracture event.However, the cause cannot be determined from the information provided.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
During broaching for a tha using the accolade broaches, the surgeon reached the desired size broach of 6- when attempting to remove the size 6 broach from the femoral canal the stub on top snapped resulting in the broach being stuck in the femoral canal.The surgeon made attempts to remove the broach but ultimately had to perform an eto and then use dal miles cables and changed femoral implant system to securfit.Additional information provided 5/12/2023: estimated surgical delay of 1 hour.The device was completely removed from the patient.

• Brand Name: SIZE 6 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: 18340883
• Report Number: 0002249697-2023-01573
• Device Sequence Number: 20518128
• Product Code: LPH
• UDI-Device Identifier: 07613327252729
• UDI-Public: 07613327252729
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2024

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: 09/30/2018
• Device Catalogue Number: 1020-5206
• Device Lot Number: B8HCD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 03/01/2024; 08/27/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 03/28/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2013
• 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: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male