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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR. PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

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STRYKER ORTHOPAEDICS-MAHWAH SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR. PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 6541-1-705E
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/11/2015
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that during a primary surgery, surgeon removed the #5 cutting block and the fixation peg from the block remained in patient's bone. Surgeon removed the peg immediately and there was no delay or adverse consequence to patient or user and surgery completed accordingly.

 
Manufacturer Narrative

An event regarding pin dissociation of a size #5 4-in-1-cutting block captured assy. Tria. Exp. Inst. Was reported. The event was confirmed. Method and results: device evaluation and results: inspection of the returned device confirmed the pin had dissociated from the device body. Additional dimensional inspection was not performed as it was confirmed the product was within scope of the associated capa. Medical records received and evaluation: not performed as there was no indication that patient factors contributed to the reported event. Device history review: all devices accepted into final stock conformed to specification. This review confirmed the device was manufactured prior to capa implementation. Complaint history review: there have been no similar previous reported events for this lot id. Conclusions: the investigation concluded that the fixation peg disassociating from the triathlon 4:1 express cutting block was caused by a manufacturing nonconformance. It was concluded that the supplier, (b)(4), had not performed the required press fit operation between the peg and block which led to the pin coming out of the assembly. Stryker reserves the right to re-evaluate this investigation if additional relevant information becomes available.

 
Event Description

It was reported that during a primary surgery, surgeon removed the #5 cutting block and the fixation peg from the block remained in patient's bone. Surgeon removed the peg immediately and there was no delay or adverse consequence to patient or user and surgery completed accordingly.

 
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Brand NameSIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR.
Type of DevicePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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 Key5316272
MDR Text Key34766420
Report Number0002249697-2015-04470
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 HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/11/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2012
Device Catalogue Number6541-1-705E
Device LOT NumberSB2S06
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/11/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/05/2007
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: 12/21/2015 Patient Sequence Number: 1
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