MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH #3 4:1 CUTTING BLOCK; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 6541-1-703

Device Problem Sticking (1597)

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

Event Date 06/16/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

After the 4 in 1 cut was complete on the femur the doctor removed the cutting block in a usual fashion.One of the posts on the back of femur stayed in place and the doctor used plier to remove.There was no delay and the doctor went about finishing the case per usual.

Manufacturer Narrative

An event regarding a fixation peg disassociating from a triathlon guide was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional and functional analysis could not be performed as the device was not returned.Medical records received and evaluation: not performed as there was no indication that patient factors contributed to the reported event.Device history review: all devices accepted into final stock conformed to specification.This review confirmed the device was manufactured prior to capa implementation.Complaint history review: there have been 3 similar previous reported events for this lot id.Conclusions: the investigation concluded that the reported fixation peg disassociating from the triathlon guide was likely caused by a manufacturing nonconformance.Inspection of the reported device would be required for confirmation.It was concluded from the scope of a capa that the supplier, (b)(6), had not performed the required press fit operation between the peg and block and had reamed the cutting block hole oversized which led to the pin coming out of the assembly.Stryker reserves the right to re-evaluate this investigation if additional relevant information becomes available.Not returned.

Event Description

After the 4 in 1 cut was complete on the femur the doctor removed the cutting block in a usual fashion.One of the posts on the back of femur stayed in place and the doctor used plier to remove.There was no delay and the doctor went about finishing the case per usual.

• Brand Name: #3 4:1 CUTTING BLOCK
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5789727
• MDR Text Key: 50185125
• Report Number: 0002249697-2016-02273
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143393
• 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: 06/16/2016

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: 6541-1-703
• Device Lot Number: SBYC04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2004
• 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: 78 YR
• Patient Weight: 65