MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY ACCOLADE LATERAL RASP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	I-H1417RS00
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2020
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.
Event or Problem Description
Primary procedure, right hip.It was reported that after broaching the femur, approximately 1 inch of the distal tip of the lateral rasp broke off inside the patient's bone.The tip was retrieved.Removal was verified by visual inspection, intra-op imaging, irrigation, and re-assembly of the device at the back table.Surgery was completed successfully with a delay of approximately 5 minutes.The device is allegedly available for return, and the rep confirmed that no further information will be available.
Event or Problem Description
Primary procedure, right hip.It was reported that after broaching the femur, approximately 1 inch of the distal tip of the lateral rasp broke off inside the patient's bone.The tip was retrieved.Removal was verified by visual inspection, intra-op imaging, irrigation, and re-assembly of the device at the back table.Surgery was completed successfully with a delay of approximately 5 minutes.The device is allegedly available for return, and the rep confirmed that no further information will be available.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a speciality accolade rasp was reported.The event was confirmed.Method & results: -device evaluation and results: the device was returned fractured.The proximal fracture surface was examined further using a scanning electron microscope (sem).The returned rasp fractured in bending overload.-medical records received and evaluation: there is no indication that patient factors contributed to the reported event.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the returned rasp fractured in bending overload.The hardness was measured to be 45 hrc meeting the drawing requirement of 38 hrc min.Energy dispersive spectroscopy showed that the rasp was consistent with 17-4ph stainless steel which is consistent with the iteration of the drawing at the time of manufacturing.Based on the given information no material or manufacturing discrepancies were observed on the surfaces examined.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: SPECIALTY ACCOLADE LATERAL RASP
• 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: 9712707
• Report Number: 0002249697-2020-00334
• Device Sequence Number: 13953601
• Product Code: LPH
• UDI-Device Identifier: 07613327297614
• UDI-Public: 07613327297614
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 05/11/2020

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: 06/30/2015
• Device Model Number: I-H1417RS00
• Device Catalogue Number: I-H1417RS00
• Device Lot Number: ER5H01393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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: 56 YR