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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR OFFSET QUICK CONNECT INSERTER; INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH MODULAR OFFSET QUICK CONNECT INSERTER; INSTRUMENT Back to Search Results
Catalog Number 1020-1860
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2014
Event Type  malfunction  
Event Description
It was reported that when the modular offset quick connect inserter was removed from the stem, after the accolade stem was implanted with this inserter, it was difficult to be removed from the stem.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Manufacturer Narrative
Device history review: review of the device history records indicate devices were manufactured and accepted into final stock.Complaint history review: there have been no other events reported for the reported manufacturing lot.Visual: the device showed signs of minimal use.There was some minor deformation on the edge of the protrusion that mates with the stem and aligns it to the handle.Dimensional: the critical dimensions required for fit of the inserter into the stem were dimensionally inspected with caliper (b)(4).The device was found to be within specification.Functional: the device was assembled and disassembled onto an accolade ii stem.There was no adverse force required and therefore the event is not confirmed.The event could not be confirmed.The device was found to be fully functional and dimensionally correct.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 when the modular offset quick connect inserter was removed from the stem, after the accolade stem was implanted with this inserter, it was difficult to be removed from the stem.
 
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Brand Name
MODULAR OFFSET QUICK CONNECT INSERTER
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4354287
MDR Text Key5205284
Report Number0002249697-2014-04900
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeJA
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 12/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1020-1860
Device Lot NumberSC10693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received09/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2013
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;
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