MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34

Catalog Number	04.01.0162
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Preliminary investigation performed ba r&d product manager: the picture confirms that the screw was not fully seated in the baseplate hole and that the prongs were protruding off the screw seat.In addition the deformation of the prongs and the removal of the inner screw are confirmed.The hole appears to be slightly off centre considering screw seat.Clinical evaluation performed by medical affairs director: an intraoperative problem was reported after rsa.From the description of the event, no clinical origin can be discerned.It is very likely that no clinical consequence should be expected either.Batch review performed on 09-may-2018.Lot 165153: (b)(4) items manufactured and released on 15-december-2016.Expiration date: 2021-11-03.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 the glenoid polyaxial locking screw insertion some prongs of the outer screw were bent.The outer screw remained stuck in the baseplate and it could not be removed, the surgeon removed all screw prongs, using pliers, and complete the surgery successfully.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34
• Common Device Name: POLYAXIAL LOCKING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7506729
• Report Number: 3005180920-2018-00316
• Device Sequence Number: 13896965
• Product Code: PHX
• UDI-Device Identifier: 07630040706490
• UDI-Public: 07630040706490
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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: 11/03/2021
• Device Catalogue Number: 04.01.0162
• Device Lot Number: 165153
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/11/2018
• 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