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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL TORQUE WRENCH KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS

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STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL TORQUE WRENCH KNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS Back to Search Results
Catalog Number 6543-4-818
Device Problems Bent (1059); Component Falling (1105); No Apparent Adverse Event (3189)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2015
Event Type  Malfunction  
Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

 
Event Description

Scrub tech and surgeon assembled the implants, torque wrench bent while assembling causing the (2) implants to fall on the or floor. Opened (2) new implants and continued surgery implantation.

 
Manufacturer Narrative

Corrected lot number based on additional information. An event regarding user error involving a universal torque wrench was reported. The event was confirmed. Method & results: device evaluation and results: universal torque wrench showed no damage from the drop. The baseplate looks to be in new condition with no signs of damage. The baseplate was able to screw onto the stem. Medical records received and evaluation: not performed as medical records were not provided. Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: based on the device identification the complaint databases were reviewed for similar reported events regarding user error. Conclusions: the investigation determined the event to be related to misuse. The surgical protocol indicates to apply 120 in-lbs torque to the trial stem using the torque wrench. The device is designed only to reasonably withstand the maximum recommended torque measurements. The user likely applied more than the recommended 120 in-lbs, therefore resulting in the observed, and intended by design, plastic deformation. No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics. If devices and / or additional information become available, this investigation will be reopened.

 
Event Description

Scrub tech and surgeon assembled the implants, torque wrench bent while assembling causing the (2) implants to fall on the or floor. Opened (2) new implants and continued surgery implantation.

 
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Brand NameUNIVERSAL TORQUE WRENCH
Type of DeviceKNEE JOINT PATELLOFEMOROTIBIAL METAL/POLYMER POROUS-COATED UNCEMENTED PROSTHESIS
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 Key5242276
MDR Text Key32144377
Report Number0002249697-2015-03976
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132624
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 11/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6543-4-818
Device LOT NumberB36017
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/18/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/03/2013
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: 11/23/2015 Patient Sequence Number: 1
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