MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL ALIGNMENT DISTAL ASSEMBLY EM; GUIDE, SURGICAL, INSTRUMENT

Catalog Number 6541-2-610

Device Problems Fitting Problem (2183); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

When positioning 6541-6-611 into 6541-2-610 and try to lock, the lock cannot be pushed into the right positon.I'm not aware of which of the component that does not work.That's why both items are sent into investigation.

Manufacturer Narrative

An event regarding assembly issues involving a triathlon alignment guide was reported.Conclusion: a funtional inspection was performed on the returned triathlon rod (6541-6-611) and the returned triathlon guide (6541-2-610, lot rddk118).The spring locking button of the triathlon guide was found to be sticking and hard to push.A medical lubricant was added onto the locking button.After application, the spring button depressed without any difficulty and both the triathlon rod and triathlon assembly guide assembled as intended.This event meets the definition of preventive maintenance.There was no surgical procedure associated with the reported event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

When positioning 6541-6-611 into 6541-2-610 and try to lock.The lock cannot be pushed into the right positon.I'm not aware of which of the component that does not work.That's why both items are sent into investigation.

• Brand Name: TIBIAL ALIGNMENT DISTAL ASSEMBLY EM
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8302939
• MDR Text Key: 135890090
• Report Number: 0002249697-2019-00445
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07613327179705
• UDI-Public: 07613327179705
• Combination Product (y/n): N
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-2-610
• Device Lot Number: RDDK118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other