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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE #6 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 #6 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 6541-1-706E
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/25/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

While removing a size 6 triathlon 4 in 1 cutting block one of the locating pins remained in bone.

 
Manufacturer Narrative

An event regarding crack/fracture involving an triathlon guide was reported. The event was confirmed. Method & results: -device evaluation and results: the device was returned in used condition, with the disassociated fixation pin. The other pin remained assembled. The disassociated pin appeared to have broken cleanly adjacent to weld zone. Material analysis was performed which concluded that "the pin broke from multiple overloads. The eds spectrum and hardness of the material were consistent with a 17-4 ph stainless steel alloy properly heat treated to the h900 condition. No material or manufacturing defects were observed. " -medical records received and evaluation: not performed as patient factors did not contribute to the event. -device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced. Conclusions: visual inspection confirms the reported event that concludes the device was returned in used condition, with the disassociated fixation pin. The disassociated pin appeared to have broken cleanly adjacent to weld zone. Material analysis was performed which concluded that "the pin broke from multiple overloads. The eds spectrum and hardness of the material were consistent with a 17-4 ph stainless steel alloy properly heat treated to the h900 condition. No material or manufacturing defects were observed. " no further investigation for this event is possible at this time. If the additional information will be received, this investigation will be reopened and re-evaluated.

 
Event Description

While removing a size 6 triathlon 4 in 1 cutting block one of the locating pins remained in bone.

 
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Brand NameSIZE #6 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 colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5962657
MDR Text Key55431379
Report Number0002249697-2016-02991
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAU
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-1-706E
Device LOT NumberSB2C18
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/23/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/05/2007
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: 09/20/2016 Patient Sequence Number: 1
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