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

Catalog Number 04.01.0165

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Preliminary investigation performed by r&d (b)(4): as reported by the sales representative, the insertion of the screw was totally carried out with the "glenoid polyaxial screwdriver - non-retentive" (ref.(b)(4)).The use of this instrument instead of the "polyaxial screwdriver - modular tip" (ref.(b)(4)), prevents the petals from being captured, exposing the head to an increased risk of breakage.Batch review performed on 29 apr 2019: lot 174752: (b)(4) items manufactured and released on 30-jan-2018.Expiration date: 2023-01-16.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 Description

During the primary surgery the head of the screw got damaged when the surgeon tried to insert it with the screwdriver.The screw was further damaged extracting it with a pincer.The bone was sclerotic.The surgery was completed successfully using a new screw.No critical delay during the surgery and no parts fell into the patient.The "glenoid polyaxial screwdriver - non-retentive" (ref.(b)(4)) was used to insert the screw.

Manufacturer Narrative

On may 09th 2019 we discovered that the implant reference reported in the initial report was not correct.The correct reference is 04.01.0165.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW - L34
• Type of Device: POLYAXIAL SHOULDER LOCKING SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8560456
• MDR Text Key: 145767610
• Report Number: 3005180920-2019-00320
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706490
• UDI-Public: 07630040706490
• Combination Product (y/n): N
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2023
• Device Catalogue Number: 04.01.0165
• Device Lot Number: 174752
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR