MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON FULLY CAPTURED DISTAL RESECTION GUIDE PER FILE K2869; INSTRUMENT

Catalog Number I-K2869KF00

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2014

Event Type  malfunction  

Event Description

After placing the im distal resection assembly into the femur surgeon resident (b)(6) started to pin the block to the femur using a wire driver on stryker system 6 power.While driving the pin into the bone it became stuck in the cutting block and was not able to be removed.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding pin seizure involving a specialty triathlon guide was reported.The event was confirmed.Method & results: -device evaluation and results: a material analysis indicated the pin galled in the guide hole.No material or manufacturing defects were observed on the device features evaluated.-medical records received and evaluation: records were not provided.There is no indication the event is patient related.-device history review: the reported device was manufactured and accepted into final stock with no discrepancies.-complaint history review: there have been no other events for the reported lot id.Conclusions: the investigation concluded that the pin galled and seized in the guide hole.The reported device was not properly identified.However, a review of the nc/capa data base for triathlon guides and pin seizure indicates that a capa was opened to determine root cause and effective corrective action.The capa team decided that the best corrective action was to change the design of the 1/8" headless pin.Change notice was implemented to add flutes to the bottom half of the pin.The fluted pins will allow the pin to act as a drill bit and clear any burrs or debris located on the inside surfaces of the cutting blocks/guides.The reported pin is contained within the scope of the capa.

Event Description

After placing the im distal resection assembly into the femur surgeon resident pgy 5 mary ragsdale started to pin the block to the femur using a wire driver on stryker system 6 power.While driving the pin into the bone it became stuck in the cutting block and was not able to be removed.

• Brand Name: SPECIALTY TRIATHLON FULLY CAPTURED DISTAL RESECTION GUIDE PER FILE K2869
• Type of Device: INSTRUMENT
• 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 Key: 3675624
• MDR Text Key: 4258707
• Report Number: 0002249697-2014-00755
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: I-K2869KF00
• Device Lot Number: MME8EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 03/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other