MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER MODULAR RASP SM CDH; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0580-355-0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the trunnion broke off of the size 0 exeter rasp in patient and that it was not possible to reassemble rasp handle onto the rasp.
Additional Manufacturer Narrative
Reported event:  an event regarding crack/fracture involving exeter modular rasp sm cdh was reported.The event was confirmed based on inspection.Method & results: device evaluation and results: visual inspection: the device was returned in used condition and it can be observed that broach has been fractured at the notch.Ma: the broach was returned fractured at the notch.The device was examined with the aid of a stereo microscope at magnifications up to 50x.The fractured fragment was evaluated further using a scanning electron microscope (sem).The dimple and transgranular fracture morpholgies are consistent with an overload fracture.Energy dispersive spectroscopy analysis showed that the device was consistent with a 17-4 ph stainless steel (fe-cr-ni-cu) which is consistent with the drawing.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Clinician review: 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 lot referenced.Conclusion: it was reported that the trunion broke off of the size 0 exeter rasp in patient and that it was not possible to reassemble rasp handle onto the rasp.The event was confirmed based on inspection.Visual inspection: the device was returned in used condition and it can be observed that broach has been fractured at the notch.Ma: the broach was returned fractured at the notch.The device was examined with the aid of a stereo microscope at magnifications up to 50x.The fractured fragment was evaluated further using a scanning electron microscope (sem).The dimple and transgranular fracture morpholgies are consistent with an overload fracture.Energy dispersive spectroscopy analysis showed that the device was consistent with a 17-4 ph stainless steel (fe-cr-ni-cu) which is consistent with the drawing.Based on the given information no materials 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.
Event or Problem Description
It was reported that the trunion broke off of the size 0 exeter rasp in patient and that it was not possible to reassemble rasp handle onto the rasp.

• Brand Name: EXETER MODULAR RASP SM CDH
• 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: 10161834
• Report Number: 0002249697-2020-01211
• Device Sequence Number: 17049616
• Product Code: LPH
• UDI-Device Identifier: 07613327207675
• UDI-Public: 07613327207675
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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 Model Number: 0580-355-0
• Device Catalogue Number: 0580-355-0
• Device Lot Number: TDCHB18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 12/14/2020
• 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: 71 YR