MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH #5 4:1 CUTTING BLOCK; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 6541-1-705

Device Problems Sticking (1597); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Product (b)(4) became stuck in cutting block.Procedure was a tkr.No delay in surgery and no adverse consequence to the patient.

Manufacturer Narrative

Reported event: an event regarding user error involving a triathlon cutting block was reported.The event was confirmed.Method & results: device evaluation and results: the device was returned in used condition with the drill bit stuck in the cutting block.The drill is bent in an "s" shape, with the fluted area is bent inward toward the cutting block and a bend in the center of the drill bit.The drill bit could not be removed from the cutting block.Visual inspection by the material analysis team indicated that there is impact damage on one side of the flute which would explain the bend at the end of the drill.This impact could have led to the bend at the center of the drill in the cutting block.Medical records received and evaluation: not performed as medical records were not provided for review.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation determined the drill bit likely hit an object causing it to bend at the end and center of the drill bit and seize in the cutting block.No further investigation is available at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Product 3170-0000 became stuck in cutting block.Procedure was a tkr.No delay in surgery and no adverse consequence to the patient.

• Brand Name: #5 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5710475
• MDR Text Key: 48095076
• Report Number: 0002249697-2016-01899
• 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: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-1-705
• Device Lot Number: SB6V21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2012
• 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