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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ALIGNMENT HANDLE INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ALIGNMENT HANDLE INSTRUMENT Back to Search Results
Catalog Number 6541-2-807
Device Problems Clamp (757); Disconnection (1171); Insufficient Information (3190)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2015
Event Type  Malfunction  
Event Description

The material of the tibial alignment handle and patella clamp was discovered to be coming off.

 
Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

 
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. The event was not confirmed as the reported device was not returned. The damaged device was discovered during inspection; there was no surgical procedure associated with the reported event. This event meets the definition of preventive maintenance; no further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

The material of the tibial alignment handle and patella clamp was discovered to be coming off.

 
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Brand NameTIBIAL ALIGNMENT HANDLE
Type of DeviceINSTRUMENT
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 Key4867101
MDR Text Key5812144
Report Number0002249697-2015-02062
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number6541-2-807
Device LOT NumberRS6H07
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/12/2011
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: 06/24/2015 Patient Sequence Number: 1
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