MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO TS MOD. TIB. TRAY; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Catalog Number	77-4005
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2018
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 relevant reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
In order to use stem extension, keel end-cap for the scorpio ts tibial implant needed to be removed but failed.Another back-up implant was available.The back-up implant was opened and used in the surgery.Surgical delay time was appr.5-10 min.
Additional Manufacturer Narrative
Product available to stryker, returned to manufacturer on; device evaluated by mfg.An event regarding disassembly issue involving a scorpio baseplate was reported.The event was confirmed.A visual inspection was conducted and found there to be minor scratches on the top of the thread plug.There were chips along the edge of the thread plug in various areas.The underside of the baseplate and keel appear to be in good condition.There is light staining on top of the baseplate.This may have occurred during the cleaning and decontamination process.A functional analysis was conducted.A seekonic torque analyzer ma-000630 was utilized along with a 3/8 hex adaptor.The outcome of the torque measurement was 135 inch pound which is out of specification.The drawing 77-4003-at notes the thread plug torque should be within 25 ¿ 50 inch pound.No medical records were received for review with a clinical consultant.Review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for this lot.The event of disassembly issue was confirmed but the root cause was not determined.The torque wrench (ma-11462) used to assemble the thread plug to the baseplate was found to be within calibration at the time of assembly.A functional test was conducted for this device and the thread plug was unable to be removed.At this time we cannot determine why the thread plug was unable to be removed from the tibial baseplate.During the surgical procedure they tried to remove the thread plug but were unsuccessful and another device was available.We cannot determine if the correct direction used to try to disassemble the thread plug was followed.
Event or Problem Description
In order to use stem extension, keel end-cap for the scorpio ts tibial implant needed to be removed but failed.Another back-up implant was available.The back-up implant was opened and used in the surgery.Surgical delay time was appr.5-10 min.

• Brand Name: SCORPIO TS MOD. TIB. TRAY
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7400808
• Report Number: 0002249697-2018-01014
• Device Sequence Number: 1740870
• Product Code: JWH
• UDI-Device Identifier: 07613327029284
• UDI-Public: 07613327029284
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K994128
• 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): 06/19/2018

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: 07/30/2022
• Device Catalogue Number: 77-4005
• Device Lot Number: 2V6HVX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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