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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON GAP BALANCER-SIZER; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
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STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON GAP BALANCER-SIZER; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C Back to Search Results
Catalog Number I-K2710KB00
Device Problems Device Damaged Prior to Use (2284); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/27/2017
Event Type  malfunction  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported that during a tka procedure on patient's left knee, the surgeon realized the balancer instrument was damaged (nature unknown).The instrument did not register the proper femoral size.Company rep reported that this instrument was used in a case the previous day and had malfunctioned and "we thought we had fixed it".An old style a.P.Sizer which was immediately available was used instead.There was no surgical delay, no adverse affects to the patient, and that the procedure was completed successfully.
 
Manufacturer Narrative
An event regarding non-function involving a specialty guide was reported.The event was confirmed.Device evaluation and results: visual inspection of the returned device revealed that the two locking screws near the lock handle were missing.Tool marks were observed on the screw head on the back face of the device.The missing locking screws and tool marks suggest that the balancer had been disassembled.Discussion with specialty confirmed that the device was disassembled and assembled incorrectly.The specialty team was able to proper reassemble the instrument but indicated it still wouldn't function without the locking screws around the handle.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the instrument is non-functional as the locking screws near the lock handle were missing.Tool marks observed on the screw head on the back face of the device indicate the instrument was disassembled and then re-assembled incorrectly.Review of appendix 1 for instruments requiring disassembly for cleaning for total knee arthroplasty instruments did not include the device reported in this investigation.Therefore, there is no just cause for the triathlon gap balancer to be disassembled during use or preparation.
 
Event Description
It was reported that during a tka procedure on patient's left knee, the surgeon realized the balancer instrument was damaged (nature unknown).The instrument did not register the proper femoral size.Company rep reported that this instrument was used in a case the previous day and had malfunctioned and "we thought we had fixed it".An old style a.P.Sizer which was immediately available was used instead.There was no surgical delay, no adverse affects to the patient, and that the procedure was completed successfully.
 
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Brand Name
SPECIALTY TRIATHLON GAP BALANCER-SIZER
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
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
brian lauro
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6807865
MDR Text Key83312184
Report Number0002249697-2017-02566
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberI-K2710KB00
Device Lot NumberGEN9C790
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2014
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;
Patient Age50 YR
Patient Weight91
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