MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II BROACH; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	1020-5204
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an accolade rasp was reported.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a product history review is not required, as no manufacturing specific issue has been alleged.At stryker joint replacement all devices/product are manufactured through validated equipment and inspected by trained representatives through stryker¿s quality management system.Complaint history review: a complaint history review and trend detection is not required as this is a pm.Monitoring will be continued under the current quarterly trend review.Conclusion: the device was discovered during inspection.The device was not returned for evaluation.There was no surgical procedure associated with the reported event.No further investigation is required at this time.
Event or Problem Description
Trunnion broke of broach.

• Brand Name: SIZE 4 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: 19212439
• Report Number: 0002249697-2024-00665
• Device Sequence Number: 15480137
• Product Code: LPH
• UDI-Device Identifier: 07613327252620
• UDI-Public: 07613327252620
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2024

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: 1020-5204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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