MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L38

Catalog Number	04.01.0163
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 24-may-2018: lot 174286: (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 medical affairs director on 18-may-2018: intraoperative partial fracture of the locking screw meant to hold the glenoid component.The residual implant can perform correctly and fully the stabilization task, with the exception of the angular stability, which is an additional feature introduced by a proprietary device.There is no indication therefore that the clinical outcome of the rsa should be jeopardized by this event.The reasons that led to the intraoperative fracture cannot be established through the clinical investigation.Preliminary investigation performed by r&d product manager on 24-may-2018: the issue may have occurred due to the bone being very sclerotic, resulting in a particularly high resistance provided during the insertion phase, or the pilot hole being too shallow.Based on the given information, it is not possible to state which of the above mentioned scenarios is more likely to have happened.
Event or Problem Description
During screwing, the head of the screw opened.After this it was impossible to unscrew it out.Surgeon took out the inner small screw and broke the 4 flaps with a clamp, so the screw was deep enough for no impingement.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L38
• Common Device Name: GLENOID POLYAXIAL LOCKING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7544750
• Report Number: 3005180920-2018-00365
• Device Sequence Number: 177585
• Product Code: PHX
• UDI-Device Identifier: 07630040706506
• UDI-Public: 07630040706506
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 05/25/2018

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: 10/08/2022
• Device Catalogue Number: 04.01.0163
• Device Lot Number: 174286
• 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: 04/25/2018
• Initial Report FDA Received Date: 05/25/2018
• 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: 67 YR
• Patient Weight: 95