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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CUP IMPACTOR BOLT INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH CUP IMPACTOR BOLT INSTRUMENT Back to Search Results
Catalog Number 1440-2011
Device Problems Clip (758); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/29/2015
Event Type  Malfunction  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

It was reported that during a primary hip surgery 2 magnetic cup impactor tips got stuck inside 2 different cups of same part number. Surgical delay of approx 15 minutes to swap out the two cups which impactor tips got stuck in.

 
Manufacturer Narrative

An event regarding a disassembly issue for a cup impactor bolt from an associated shell was reported. The event was confirmed. A functional analysis confirmed that the cup impactor bolt could not be unscrewed by hand from the tritanium shell. Device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies. The complaint history review indicated there have been no other similar events for the reported lot.

 
Event Description

It was reported that during a primary hip surgery 2 magnetic cup impactor tips got stuck inside 2 different cups of same part number. Surgical delay of approx 15 minutes to swap out the two cups which impactor tips got stuck in.

 
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Brand NameCUP IMPACTOR BOLT
Type of DeviceINSTRUMENT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NJ NA
Manufacturer Contact
sandra spokane
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5096407
MDR Text Key26750245
Report Number0002249697-2015-03127
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK143085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1440-2011
Device LOT NumberDC232513
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/20/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/24/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/23/2015 Patient Sequence Number: 1
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