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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. INSTRUMENT

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STRYKER ORTHOPAEDICS-MAHWAH SIZE #6 4-IN-1 CUTTING BLOCK CAPTURED ASSY TRIA. EXP. INSTR. INSTRUMENT Back to Search Results
Catalog Number 6541-1-706E
Device Problems Pin (906); Device Slipped (1584); Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2015
Event Type  Malfunction  
Event Description

During triathlon primary knee replacement surgery (sales rep was in attendance at the case), one of the pins came off the back of a triathlon 4-in-1 cutting block.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

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 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. As a result, nonconformance pr was previously raised on apr-2013. The supplier investigation, scope and corrective actions are detailed within the nc and corresponding capa.

 
Event Description

During triathlon primary knee replacement surgery (sales rep was in attendance at the case), one of the pins came off the back of a triathlon 4-in-1 cutting block.

 
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Brand NameSIZE #6 4-IN-1 CUTTING BLOCK CAPTURED ASSY TRIA. EXP. INSTR.
Type of DeviceINSTRUMENT
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
william hanna
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key4551286
MDR Text Key5524221
Report Number0002249697-2015-00462
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK123486
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2015
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 NumberSB2V26
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/23/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/15/2008
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: 02/26/2015 Patient Sequence Number: 1
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