MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM L

Catalog Number	02.12.0214FL
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 january 2018 lot 144237: (b)(4) items manufactured and released on 18 september 2014.Expiration date: 2019-08-31 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs on 26 january 2018: one year after primary tka the insert fixation screw got loose in the joint.It was immediately removed with an arthroscopic operation.No consequence should be expected for the absence of the screw in the future life of the implant.The cause for self-unscrewing of the insert screw is not known: one possibility is insufficient tightening torque but other unknown conditions may also play a role.
Event or Problem Description
Inlay locking screw arthroscopic removal due to unscrewing.Torque limiting screwdriver was not used in primary surgery.
Additional Manufacturer Narrative
Visual inspection of the returned screw by r&d product manager: one year after primary tka the insert fixation screw got loose in the joint, it was removed arthroscopically.From visual inspection, the screw doesn't present any anomalies and looks conform to the specifications required.Metrological control confirmed that the screw is in compliance with the dimensional specifications required.The cause for the unscrewing of the insert screw is not known: the only cause that we can suppose, but not possible to be verified, it is insufficient tightening torque, due to improper use of torque limiter screwdriver (limiting torque was not reached).
Additional Manufacturer Narrative
R&d product manager reported the following investigation: one year after primary tka the insert fixation screw got loose in the joint, it was removed arthroscopically.From visual inspection, the screw doesn't present any anomalies and looks conform to the specifications required.Metrological control confirmed that the screw is in compliance with the dimensional specifications required.The cause for the unscrewing of the insert screw is not known: the only cause that we can suppose, but not possible to be verified, it is insufficient tightening torque, due to improper use of torque limiter screwdriver (limiting torque was not reached).As reported in the event description the torque limiter was not used during primary surgery.For this reason the visual inspection has been updated on 05 april 018 by the r&d product manager, reporting the following: one year after primary tka the insert fixation screw got loose in the joint, it was removed arthroscopically.From visual inspection, the screw doesn't present any anomalies and looks conform to the specifications required.Metrological control confirmed that the screw is in compliance with the dimensional specifications required.The cause for the unscrewing of the insert screw is not known: the only cause that we can suppose, but not possible to be verified, it is insufficient tightening torque.

• Brand Name: TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7221024
• Report Number: 3005180920-2018-00004
• Device Sequence Number: 19266637
• Product Code: JWH
• UDI-Device Identifier: 07630030826214
• UDI-Public: 07630030826214
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 02.12.0214FL
• Device Lot Number: 144237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/29/2017
• Supplement Date Received by Manufacturer: 12/29/2017; 12/29/2017
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 03/23/2018; 04/06/2018
• 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: Required Intervention