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

Model Number	1020-5206
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
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 other similar events for the lot referenced.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 : not available.
Event or Problem Description
It was reported, "when hammering in the hip rasp, the base of the hip rasp broke off." additional information: when the femoral shaft was rasped open, the connecting pin between the handle and the rasp broke off.The rasp could be removed from the femur without any problems, the fracture was only noticed when the next larger rasp was used should be inserted into the handle.As per sales rep: "no bone fracture.".
Event or Problem Description
It was reported, "when hammering in the hip rasp, the base of the hip rasp broke off." additional information: when the femoral shaft was rasped open, the connecting pin between the handle and the rasp broke off.The rasp could be removed from the femur without any problems, the fracture was only noticed when the next larger rasp was used should be inserted into the handle.As per sales rep: "no bone fracture.".
Additional Manufacturer Narrative
Reported event an event regarding crack/fracture involving a accolade reamer was reported.The event was confirmed by visual 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.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 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.The exact cause of the event could not be determined because insufficient information was provided.Further information such as the primary operative report are needed to complete the investigation for determining root cause.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.

• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17056890
• Report Number: 0002249697-2023-00617
• Device Sequence Number: 18327728
• Product Code: LPH
• UDI-Device Identifier: 07613327252729
• UDI-Public: 07613327252729
• 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): 08/14/2023

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 Expiration Date: 01/31/2018
• Device Model Number: 1020-5206
• Device Catalogue Number: 1020-5206
• Device Lot Number: B7TCW
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2013
• 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: Other
• Patient Sex: Unknown