MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ALIGNMENT HANDLE; INSTRUMENT

Catalog Number 6541-2-807

Device Problems Sticking (1597); Failure to Advance (2524)

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

Event Date 09/12/2013

Event Type  malfunction  

Event Description

It was reported that the surgeon made comments re the design of the triathalon tibial trial baseplate #2, and #1.The alignment handle does not release and gets stuck.The surgeon is concerned that while trying to get handle out during surgery will stab knee.

Event Description

It was reported that the surgeon made comments re the design of the triathalon tibial trial baseplate #2, and #1.The alignment handle does not release and gets stuck.The surgeon is concerned that while trying to get handle out during surgery will stab knee.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as unknown triathlon alignment handle.Additional information has been requested and if received will be submitted in a follow up report upon completion of the investigation.Device not returned to manufacturer.

Manufacturer Narrative

An event regarding an alignment handle becoming stuck on baseplate trials involving a tibial alignment handle was reported.The event was not confirmed.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.

• Brand Name: TIBIAL ALIGNMENT HANDLE
• Type of Device: INSTRUMENT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3706015
• MDR Text Key: 4338180
• Report Number: 0002249697-2014-00928
• Device Sequence Number: 1
• Product Code: JWH
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-2-807
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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