MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON BOX CUT GUIDE-NO FEET-2MM DEEP SIZE 2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number I-K2380CG02

Device Problems Material Discolored (1170); Device Operates Differently Than Expected (2913); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while performing a tka of patient's left knee, surgeon used a 4-in-1 cutting guide.After cutting, surgeon attempted to put the custom box guide on (custom: no posterior feet or chisel) and the champers would not engage.Surgeon resolution was to manually clean the cuts in order to make the femoral component fit.Surgeon reported dissatisfaction with the sub-optimal solution, but found it acceptable to complete the procedure in this manner.

Manufacturer Narrative

An event regarding size/fit issue involving a speciality triathlon box cut guide reported.The event was not confirmed.Method & results: -device evaluation and results: the device was returned in used condition.There are scratches and discoloration throughout.Review of device by a material analysis engineer indicated: "damage observed on guides consistent with in-service use." -medical records received and evaluation: not performed as no medical records received.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the event was not confirmed as the device was returned damaged and a dimensional or functional could not be performed.Review of device by a material analysis engineer indicated: "damage observed on guides consistent with in-service use." no further investigation for this event is possible at this time.If the additional information will be received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that while performing a tka of patient's left knee, surgeon used a 4-in-1 cutting guide.After cutting, surgeon attempted to put the custom box guide on (custom: no posterior feet or chisel) and the champers would not engage.Surgeon resolution was to manually clean the cuts in order to make the femoral component fit.Surgeon reported dissatisfaction with the sub-optimal solution, but found it acceptable to complete the procedure in this manner.

• Brand Name: SPECIALTY TRIATHLON BOX CUT GUIDE-NO FEET-2MM DEEP SIZE 2
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6933086
• MDR Text Key: 89948646
• Report Number: 0002249697-2017-02947
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

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-K2380CG02
• Device Lot Number: F5W12278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 12/06/2017
• Supplement Dates FDA Received: 01/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR