• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PATELLA CLAMP INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH PATELLA CLAMP INSTRUMENT Back to Search Results
Catalog Number 6541-3-600
Device Problems Clamp (757); Material Deformation (2976); Material Integrity Problem (2978); Mechanics Altered (2984)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2015
Event Type  Malfunction  
Event Description

Clamp would not lock when squeezed fully. Surgeon had to hold pressure on handle while cement set up.

 
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.

 
Manufacturer Narrative

An event regarding a handle that did not stay locked involving a triathlon patella clamp was reported. The event was confirmed. Method & results: device evaluation and results: visual and functional analysis confirmed the reported event. Medical records received and evaluation: not performed as medical records were not provided for evaluation. Device history review: all products were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been other events for this lot. Conclusions: the investigation determined that the reported failure has been previously investigated. An ecn was implemented to correct the reported failure. The returned device was confirmed to be manufactured before the ecn.

 
Event Description

Clamp would not lock when squeezed fully. Surgeon had to hold pressure on handle while cement set up.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePATELLA CLAMP
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
keyla navedo
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4879078
MDR Text Key19310362
Report Number0002249697-2015-02147
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 Other,Health Professional,HEALTH PROFESSIONAL,OTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-3-600
Device LOT NumberCXW01E
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/17/2005
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/18/2004
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/30/2015 Patient Sequence Number: 1
-
-