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

Catalog Number	6541-2-610
Medical Device Problem Codes	Fitting Problem (2183); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8302939
• Report Number: 0002249697-2019-00445
• Device Sequence Number: 16556524
• Product Code: FZX
• UDI-Device Identifier: 07613327179705
• UDI-Public: 07613327179705
• Combination Product (Y/N): N
• PMA/510(K) Number: K123486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other