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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, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

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STRYKER ORTHOPAEDICS-MAHWAH SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR. PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Catalog Number 6541-1-705E
Device Problems Break (1069); Device Dislodged or Dislocated (2923); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Event Date 05/26/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The surgeon mr (b)(6), reported that a piece broke off the triathlon cutting block during surgery. The surgeon further reported that he impacted the device and when he took it off one of two metal 'spikes' had broken off the device and remained lodged in the patient's bone. The surgeon was able to remove the piece from the patient with no lasting effect. There was a 2-3 minute delay to surgery as a result of the reported event. The case was completed successfully.

 
Manufacturer Narrative

An event regarding pin dissociation of a triathlon guide was reported. The event was confirmed. Method & 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 2 similar previous reported events. 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

The surgeon mr (b)(6), reported that a piece broke off the triathlon cutting block during surgery. The surgeon further reported that he impacted the device and when he took it off one of two metal 'spikes' had broken off the device and remained lodged in the patient's bone. The surgeon was able to remove the piece from the patient with no lasting effect. There was a 2-3 minute delay to surgery as a result of the reported event. The case was completed successfully.

 
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Brand NameSIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR.
Type of DevicePROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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 Key5745826
MDR Text Key48758481
Report Number0002249697-2016-02030
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeGB
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 05/27/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6541-1-705E
Device LOT NumberSB1W02
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/22/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/07/2007
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: 06/23/2016 Patient Sequence Number: 1
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