MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 2MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5570-S-020
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
During revision, the nut was missing in the offset.
Additional Manufacturer Narrative
An event regarding a missing component involving a triathlon adaptor was reported.The event was confirmed.The device was returned in new condition.It was confirmed the nut was missing in the offset.Medical records received and evaluation: not performed as medical records were not provided for review.A device history review confirmed all devices accepted into finished goods conformed to specification.There have been no other events for the lot referenced.This investigation exhibited a non conformance.Nc has been opened on (b)(6) 2018 to further investigate missing component.Due to the information and the historical nature of this isolated event, it cannot be definitively concluded that the problem occurred within stryker¿s control.It is unclear whether the issue occurred within or outside of stryker's control.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.
Event or Problem Description
During revision, the nut was missing in the offset.

• Brand Name: TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 2MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7096491
• Report Number: 0002249697-2017-03506
• Device Sequence Number: 1378829
• Product Code: MBH
• UDI-Device Identifier: 07613327014990
• UDI-Public: 07613327014990
• Combination Product (Y/N): N
• PMA/510(K) Number: K141056
• 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): 02/21/2018

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 Expiration Date: 11/24/2020
• Device Catalogue Number: 5570-S-020
• Device Lot Number: 0040305A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 02/21/2018
• 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