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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 Fracture (1260); Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/12/2015
Event Type  malfunction  
Event Description
Revision of competitor (biomet) product.During the revision, the extractor cross threaded.No delay or adverse consequence to patient.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
The event regarding the extractor cross threading was confirmed.Visual inspection confirmed the reported event - the threads fractured.A material analysis was not performed, as thread damage/fracture is a known failure.The fracture surface is consistent with an overload 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.The event was confirmed but no material or manufacturing defects were observed on the device features examined.Product surveillance will continue to monitor for trends.
 
Event Description
Revision of competitor (biomet) product.During the revision, the extractor cross threaded.No delay or adverse consequence to patient.
 
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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 Key4839189
MDR Text Key5914423
Report Number0002249697-2015-01893
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 Other,Health Professional,health professional,oth
Reporter Occupation Other
Type of Report Initial
Report Date 05/14/2015
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
Device Operator Health Professional
Device Catalogue Number6260-4-090
Device Lot NumberTDER400
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/14/2015
Initial Date FDA Received06/11/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/13/2014
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 Outcome(s) Other;
Patient Age83 YR
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