MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL RESECTION GUIDE MODULAR CAPTURE LT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-2-703

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report.Not returned to the manufacturer.

Event Description

Capture on tibial cutting blocks jam stuck after clipping in.

Manufacturer Narrative

An event regarding seizing involving a triathlon modular capture guide was reported.Review of the device history records indicate 24 devices were manufactured and accepted into final stock on 23-jul-2014 with no reported discrepancies.Visual inspection: the tibial resection guide modular capture rt was returned in used condition.The device exhibited burnishing and scratch marks on the cutting slot surfaces.Review of the device by the material analysis engineer indicated "damage observed is consistent with reported event." functional inspection: the modular capture easily mated with the resection guide.The device was tested and found to be functionally acceptable with a mating component from finished goods (catalog 6541-2-701, lot afyt04) dimensional inspection: cannot be performed as the device was returned used/damaged.Based on the device identification the complaint databases were reviewed from 2014 to present for similar reported events regarding seizing.Lot id there have been no other events for the lot referenced.Conclusion: the damaged device was discovered during inspection.Visual inspection of the returned devices exhibited burnishing and scratch marks on the cutting slot surfaces.Review of the device by the material analysis engineer indicated "damage observed is consistent with reported event." however, the devices are found to be functional acceptable with a mating component from finished goods.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Capture on tibial cutting blocks jam stuck after clipping in.

• Brand Name: TIBIAL RESECTION GUIDE MODULAR CAPTURE LT
• Type of Device: PROSTHESIS, 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5995274
• MDR Text Key: 56333663
• Report Number: 0002249697-2016-03114
• 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: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-2-703
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 74 YR