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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 02.Sep.2019.Lot 184569: 303 items manufactured and released on 15-jan-2019.Expiration date: 2023-12-05.No anomalies found related to the problem.To date, 65 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
During the primary reverse shoulder surgery and while inserting the 30mm glenoid polyaxial locking screw, the tabs on the screw head bent causing the screw not to seat or lock.The surgeon removed the screw and was able to successfully implant, seat and lock the new screw.There was no delay in the case and the surgery was completed successfully.

• 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, 6874 ; SZ 6874
• MDR Report Key: 9080726
• Report Number: 3005180920-2019-00779
• Device Sequence Number: 1735253
• Product Code: PHX
• UDI-Device Identifier: 07630040706483
• UDI-Public: 07630040706483
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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: 12/05/2023
• Device Catalogue Number: 04.01.0161
• Device Lot Number: 184569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/18/2019
• 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