MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DISTAL RESECTION GUIDE - STANDARD; INSTRUMENT

Catalog Number 6541-1-721

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

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

Event Date 05/26/2015

Event Type  malfunction  

Event Description

Distal cutting block would not allow 3170-0000 pins pass through the cross pin hole.Hole seemed to be smaller on one side.Tried different pins, eventually getting fixation and making cut.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding a pin seizing in a resection guide was reported.The event was confirmed during visual and functional evaluations.Method & results: -device evaluation and results: a functional analysis confirms the pin could not pass through the guide.A visual inspection showed material transfer.This confirms the event.-medical records received and evaluation: not performed because patient factors did not contribute to the event.-device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events reported for this manufacturing lot.Conclusions: this event is related to events where the headless pins may deposit material on the inside surface of the hole.This can lead to the galling (binding) of the pin inside of the hole.A capa was opened in january 2005 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, via the ecn process, by adding flutes to the bottom half of the pin.The flutes 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.

Event Description

Distal cutting block would not allow 3170-0000 pins pass through the cross pin hole.Hole seemed to be smaller on one side.Tried different pins, eventually getting fixation and making cut.

• Brand Name: DISTAL RESECTION GUIDE - STANDARD
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4859053
• MDR Text Key: 5870325
• Report Number: 0002249697-2015-02006
• Device Sequence Number: 1
• Product Code: MBH
• 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,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2015

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: 6541-1-721
• Device Lot Number: C1W06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/19/2007
• 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
• Patient Age: 67 YR