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

Catalog Number	77-4005
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Material Distortion (2977)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/01/2018
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 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
The surgeon couldn't unscrew the locking screw on the scorpio ts tibial tray for using stem extension, during the surgery.So, the surgeon changed to another scorpio ts tibial tray w/ different lot number for surgery closing.There was 5 ~ 10 min.Delay of surgery, due to the problem.Left knee.
Additional Manufacturer Narrative
Corrected data: device evaluated by mfg.An event regarding unlocking the screw involving a scorpio tibial baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: a functional inspection was conducted with an sme, operations engineer and technical services.Drawing cd-77-4003-at scorpio total stabilizer total knee tibial tray #3-13 rev c noted in number 2 thread plug (76-0001) must be assembled with 25-50 in-lb of torque.A manual torque wrench proto 39825a was used to determine if the screw at the bottom of the baseplate is within tolerance.The manual torque wrench was able to remove the screw with 35 in-lb of torque which is within the specified tolerance.A material analysis was conducted by a material analysis engineer and stated that ¿damage observed on threads of both components.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.¿ medical records received and evaluation: not performed because no medical records or x-rays were made available for evaluation.Product 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 reported event of ¿the surgeon couldn¿t unscrew the locking screw on the scorpio ts tibial tray¿ was not confirmed based on a functional test conducted with the returned device and an operations engineer sme.The functional test resulted that the device screw was within specification of the noted tolerance on the drawing which was between 25-50 in lb.The actual removal tolerance with a manual torque wrench was 35 in lb.A material analysis engineer did observe damages on both threaded components but there was no manufacturing discrepancies observed on the surfaces examined.
Event or Problem Description
The surgeon couldn't unscrew the locking screw on the scorpio ts tibial tray for using stem extension, during the surgery.So, the surgeon changed to another scorpio ts tibial tray w/ different lot number for surgery closing.There was 5 ~ 10 min.Delay of surgery, due to the problem.Left knee.

• Brand Name: SCORPIO TS MOD. TIB. TRAY
• 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: 7309198
• Report Number: 0002249697-2018-00602
• Device Sequence Number: 1090902
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: 07/31/2022
• Device Catalogue Number: 77-4005
• Device Lot Number: 5V868TA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/04/2018
• 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