MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MCREYNOLDS IMPACTOR ADAPTER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6260-4-090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
During a revision of a competitor hip, the mcreynolds adapter was found to have a broken threaded portion.Discovery was made before it was going to be used.A second device was used to complete the procedure successfully with no delay.Rep confirmed the device is allegedly available for return, and otherwise confirmed that no further information will be released.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a mcreynolds impactor adapter was reported.The event was confirmed.Method & results: product evaluation and results: material evaluation was completed and indicated the following comments: the tip of the mcreynolds adapter was returned fractured.The device was evaluated with a scanning electron microscope (sem).The observed mixed mechanism morphology is consistent with an overload fracture.Energy dispersive spectroscopy (eds) showed that the material is consistent with a 455 alloy (fe-cr-ni-cu-ti) which is consistent with the drawing.Hardness was evaluated, and the average hardness of 52hrc meets the drawing requirement of 47hrc minimum. based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: not performed as no medical information was received for review.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been no other similar events for the reported lot.Conclusions: material evaluation was indicated that the observed mixed mechanism morphology is consistent with an overload fracture.The material is consistent with a 455 alloy (fe-cr-ni-cu-ti) which is consistent with the drawing.Hardness was evaluated, and the average hardness of 52hrc meets the drawing requirement of 47hrc minimum. based on the given information, no identifiable 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
During a revision of a competitor hip, the mcreynolds adapter was found to have a broken threaded portion.Discovery was made before it was going to be used.A second device was used to complete the procedure successfully with no delay.Rep confirmed the device is allegedly available for return, and otherwise confirmed that no further information will be released.

• Brand Name: MCREYNOLDS IMPACTOR ADAPTER
• 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: 10210830
• Report Number: 0002249697-2020-01331
• Device Sequence Number: 2668625
• Product Code: LPH
• UDI-Device Identifier: 07613327217896
• UDI-Public: 07613327217896
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: 05/31/2017
• Device Model Number: 6260-4-090
• Device Catalogue Number: 6260-4-090
• Device Lot Number: TDEN403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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