MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MCREYNOLDS IMPACTOR ADAPTER; SCREW, FIXATION, BONE

Model Number	6260-4-090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a gmrs adaptor was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the threaded tip is fractured.Material analysis: a material analysis was performed and indicated the following: "the instrument failed in overload rapidly due to high stresses from torque, bending and pulling applied during the surgery.It is likely that there was a small amount of fatigue fracture length that had initiated at the minor diameter of the thread closest to the radius.The long length and small tip diameter are consistent with the ability to apply a high amount of stress to the tip.After investigating the instrument, no material non-conformances, nor manufacturing defects were found on any surfaces analyzed herein." clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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.Conclusions: it was reported that the gmrs adaptor broke during surgery.It was reported that the surgeon was applying extreme force.Visual inspection of the returned device indicated that the threaded tip is fractured.A material analysis was performed and indicated the following: "the instrument failed in overload rapidly due to high stresses from torque, bending and pulling applied during the surgery.It is likely that there was a small amount of fatigue fracture length that had initiated at the minor diameter of the thread closest to the radius.The long length and small tip diameter are consistent with the ability to apply a high amount of stress to the tip.After investigating the instrument, no material non-conformances, nor manufacturing defects were found on any surfaces analyzed herein." no further investigation for this event is possible 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 as a result of the breakage of the mcreynolds adaptor, the surgeon had to perform an extended trochanteric osteotomy to remove the stem.

• Brand Name: MCREYNOLDS IMPACTOR ADAPTER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14988939
• Report Number: 0002249697-2022-01003
• Device Sequence Number: 1777743
• Product Code: HWC
• UDI-Device Identifier: 07613327217896
• UDI-Public: 07613327217896
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2009
• Device Model Number: 6260-4-090
• Device Catalogue Number: 6260-4-090
• Device Lot Number: TACDB25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown