MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30; GLENOID LOCKING SCREW

Catalog Number	04.01.0161
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary investigation performed by r&d shoulder manager: as reported by the event description, the breakage of the screw may have been caused by a malalignment between the screwdriver and the screw.Batch review performed on 14 december 2018; lot 174744: (b)(4) items manufactured and released on 25 january 2018.Expiration date: 2023-01-15.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.
Event or Problem Description
During surgery the prongs of the glenoid polyaxial locking screw broke.The prongs and the inner locking screw were removed, the body of the outer locking screw was left in place.The breakage of the screw happened when it came in contact with the metaglene.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L30
• Common Device Name: GLENOID LOCKING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8164768
• Report Number: 3005180920-2018-01007
• Device Sequence Number: 1684378
• Product Code: PHX
• UDI-Device Identifier: 07630040706483
• UDI-Public: 07630040706483
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

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: 01/15/2023
• Device Catalogue Number: 04.01.0161
• Device Lot Number: 174744
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/14/2018
• 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
• Patient Age: 66 YR