MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DISTAL RESECTION GUIDE - STANDARD; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-1-721

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); Torn Material (3024)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The triathlon saw capture would not snap into the distal femoral cutting block.We opened a new saw capture but it also would not snap into the cutting block.The cutting block has signs of wear and tear.

Manufacturer Narrative

An event regarding an assembly issue with a modular saw capture involving a distal resection guide was reported.The event was not confirmed.Method & results: -device evaluation and results: the guide showed signs of scratches on its top surface consistent with its use as a guide for the saw.The device is also found to be functional as it assembled successfully with its mating modular capture.-medical records received and evaluation: not performed because no patient clinical information was provided as there is no evidence to support the event was related to patient factors.-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: the reported event is not confirmed as the device was found to be functional as it assembled successfully with the modular capture.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

The triathlon saw capture would not snap into the distal femoral cutting block.We opened a new saw capture but it also would not snap into the cutting block.The cutting block has signs of wear and tear.

• Brand Name: DISTAL RESECTION GUIDE - STANDARD
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5209621
• MDR Text Key: 31005928
• Report Number: 0002249697-2015-03673
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2015
• 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: SMM9S00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2014
• 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: 89 YR