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

Catalog Number	04.01.0162
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 18 june 2019: lot 174285: (b)(4) items manufactured and released on 12 october 2017.Expiration date: 2022-10-08.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical director: fracture of a glenoid fixation screw during rsa surgery.The screw was exchanged and no parts apparently remained in the body out of their place.No clinical consequence is to be expected.We cannot determine if the fracture was caused by an anomaly.
Event or Problem Description
The surgeon, at the time of screw fixation, found that the small glenoid polyaxial screw head broke.The surgeon commented that the screw was in axes and the correct instrument was used during surgery so he left the screw in place.The head of the screw was lost during surgery, x-rays post op do not show any screw head in the area.No delay reported during surgery.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34
• Common Device Name: SHOULDER POLYAXIAL SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8721537
• Report Number: 3005180920-2019-00491
• Device Sequence Number: 2065543
• Product Code: PHX
• UDI-Device Identifier: 07630040706490
• UDI-Public: 07630040706490
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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: 10/08/2022
• Device Catalogue Number: 04.01.0162
• Device Lot Number: 174285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/21/2019
• 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
• Patient Age: 77 YR
• Patient Weight: 70