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 Consequences Or Impact To Patient (2199)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Rupture of the rasp handle on the accolade ii rasp # 4.Surgery on the left leg.Rasp could be hardly removed from femur.
Event or Problem Description
Rupture of the rasp handle on the accolade ii rasp # 4.Surgery on the left leg.Rasp could be hardly removed from femur.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an accolade broach was reported.The event was confirmed.Method & results: device evaluation and results: the device was returned fractured at the notch.The assessment confirms that the location of the fracture is consistent with similar events reported for this product.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all 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 reported lot.Conclusion: the reported event was confirmed.While the reporter of this event reported that the broach ¿ruptured,¿ the assessment confirms that the location of the fracture is consistent with similar events reported for this product.Although the definitive root cause could not be determined, similar events shown the root cause to be fractured due to overload.If further information becomes available this investigation will be re-opened.

• 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
• MDR Report Key: 8353536
• Report Number: 0002249697-2019-01102
• Device Sequence Number: 2127254
• Product Code: LPH
• UDI-Device Identifier: 07613327252620
• UDI-Public: 07613327252620
• Combination Product (Y/N): N
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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: 07/31/2022
• Device Catalogue Number: 1020-5204
• Device Lot Number: 139491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR