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	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
Instrument is inspected after cleaning and the fault is discovered at steril centralen.It was not discovered during the operation and no replacement was used.Instrument returned for examination.The tip/threads at the end was broken off.
Additional Manufacturer Narrative
Reason for supp: product return - pm reported event: an event regarding crack/ fracture involving a gmrs adapter was reported.Conclusion: the device was discovered during inspection.The device was returned for evaluation.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 per astm e18, and the average hardness of 51hrc meets the drawing requirement of 47hrc minimum. based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.
Event or Problem Description
Instrument is inspected after cleaning and the fault is discovered at steril centralen.It was not discovered during the operation and no replacement was used.Instrument returned for examination.The tip/threads at the end was broken off.

• 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: 10483667
• Report Number: 0002249697-2020-01793
• Device Sequence Number: 19527883
• Product Code: LPH
• UDI-Device Identifier: 07613327217896
• UDI-Public: 07613327217896
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2020

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: 01/01/2020
• Device Model Number: 6260-4-090
• Device Catalogue Number: 6260-4-090
• Device Lot Number: TDER900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 11/26/2020
• 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: 70 YR