MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/10MM; TIBIAL INSERT FIXED

Catalog Number	02.07.0510PSF
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received on 28 june 2017 and includes: a torque limiting driver was not used in this case.On 21 june 2017 the medical affairs director performed a clinical investigation and commented as follows: according to the report, the insert fixation screw loosened 3 months after primary surgery.The single projection x-ray provided doesn't allow a proper clinical investigation.This event may be caused by insufficient tightening torque but the real cause can't be determined.Immediate removal is strongly recommended.During arthroscopy visual inspection of articular surfaces can be performed in order to evaluate possible damages.On 25 june 2017 the rand d project manager performed a preliminary investigation based on the available picture and commented as follows: loosened insert safety screw occurred 3 after primary surgery removed by arthroscopy.The threaded part and the head of the screw look damaged.The screw has been plastically deformed once, backed out from the baseplate, was interposed between the femoral component and the tibia insert and underwent to the body load.No other components are expected to be explanted.It seems that their articular surfaces are well preserved.The most-likely cause for self-unscrewing of the screw after few months from implantation, was insufficient tightening torque.Using a screwdriver provided with a torque limitation would prevent this event.Torque limiter screwdriver is already available and its use is mandatory.Batch review performed on 25 july 2017.(b)(4).
Event or Problem Description
The patient came in complaining of pain.The surgeon determined the poly screw backed out.The surgeon removed the screw via arthroscopic surgery.The surgery was completed successfully.X-rays are available.Explants are not available.

• Brand Name: GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/10MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6746480
• Report Number: 3005180920-2017-00411
• Device Sequence Number: 1539478
• Product Code: JWH
• UDI-Device Identifier: 07630030818226
• UDI-Public: 07630030818226
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 02.07.0510PSF
• Device Lot Number: 142828
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 07/27/2017
• 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: Required Intervention