MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #3 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	82-7-0315
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	12/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that it was found there was a foreign body on the surface of x3 insert, when tka surgery just before opening real implant.
Additional Manufacturer Narrative
An event regarding foreign matter involving a scorpio nrg x3 ps tibial insert #3 15mm was reported.The event was confirmed.Method & results: -device evaluation and results: the device was returned in its original box.The outer blister was not returned but the tyvek lid was included in the box along with the stickers and insert.The inner blister was unopened.There was a small black speck on the insert by the locking wire.-medical records received and evaluation: not performed as no adverse consequences to the patient were reported.-device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the investigation concluded that debris found in the packaging, the exact cause could not be determined.A capa investigation was initiated to further investigate.Root cause identified significant steps involving the cleanliness and control of the room and components.Cleaning procedures and maintenance processes will be revised to maintain the control room, proper machine usage training will be provided, debris attractive materials will be utilized, and supplier cleanliness control will be enforced.
Event or Problem Description
It was reported that it was found there was a foreign body on the surface of x3 insert, when tka surgery just before opening real implant.

• Brand Name: SCORPIO NRG X3 PS TIBIAL INSERT #3 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6243481
• Report Number: 0002249697-2017-00185
• Device Sequence Number: 1025892
• Product Code: JWH
• UDI-Device Identifier: 07613327030907
• UDI-Public: (01)07613327030907(11)150904(17)200930(10)842YDL
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2017

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: 09/30/2020
• Device Catalogue Number: 82-7-0315
• Device Lot Number: 842YDL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2017
• Supplement Report FDA Received Date: 05/08/2017
• 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