MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW L26; SHOULDER GLENOID POLYAXIAL LOCKING SCREW

Catalog Number	04.01.0160
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 07 march 2019: lot 182293: (b)(4) items manufactured and released on 04-sep-2018.Expiration date: 2023-08-23.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 director: screw breakage during implantation.The screw was replaced by a new one and surgery was completed successfully.No clinical consequence is expected for this event.
Event or Problem Description
The surgeon may have misplaced the screw during surgery and the head of the screw broke.He decided to use another screw to complete the case.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW L26
• Common Device Name: SHOULDER GLENOID POLYAXIAL LOCKING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8403057
• Report Number: 3005180920-2019-00134
• Device Sequence Number: 13531172
• Product Code: PHX
• UDI-Device Identifier: 07630040706476
• UDI-Public: 07630040706476
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/08/2019

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: 08/23/2023
• Device Catalogue Number: 04.01.0160
• Device Lot Number: 182293
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 03/08/2019
• 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