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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MCREYNOLDS IMPACTOR ADAPTER; INSTRUMENT
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STRYKER ORTHOPAEDICS-MAHWAH MCREYNOLDS IMPACTOR ADAPTER; INSTRUMENT Back to Search Results
Catalog Number 6260-4-090
Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)
Patient Problems Unspecified Infection (1930); No Consequences Or Impact To Patient (2199)
Event Date 04/15/2014
Event Type  malfunction  
Event Description
It was reported that there was a left revision of the hip due to infection.While trying to remove the stem the surgeon attempted to backslap and the handle for the extractor broke as well as the mcreynolds adapter.There was reportedly no delay in surgery.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
The event was confirmed.A material analysis was performed and concluded the following for the adaptor: the adapter fractured in overload caused by the application of an off-axis load.The fracture initiated at the root diameter of the second thread closest to the adapter body.The eds spectrum of the material was consistent with a custom 455 stainless steel alloy heat treated to the h900 condition.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Conclusion: the adapter fractured in overload caused by the application of an off-axis load.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.
 
Event Description
It was reported that there was a left revision of the hip due to infection.While trying to remove the stem the surgeon attempted to backslap and the handle for the extractor broke as well as the mcreynolds adapter.There was reportedly no delay in surgery.
 
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Brand Name
MCREYNOLDS IMPACTOR ADAPTER
Type of Device
INSTRUMENT
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
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key3781169
MDR Text Key4437292
Report Number0002249697-2014-01687
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number6260-4-090
Device Lot NumberPACL506
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received09/24/2015
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age75 YR
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