MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER GENERAL GLENOID POLYAXIAL SCREWDRIVER - NON-RETENTIVE; SURGICAL INSTRUMENT FOR SHOULDER SURGERIES

Catalog Number	04.01.10.0284
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on january 15, 2019.Lot 1752863: (b)(4) items manufactured and released on 11 october 2017.No anomalies found related to the issue.To date, other 4 similar event on the same lot has been registered.Visual inspection performed by r&d project manager on january 15, 2019.The instrument's tip resulted damaged: one of the four teeth on the extremity was broke.The teeth are the protrusions of the shaft, in order to connect the relative screw and transmit the adequate torque to tighten the implant on its position.The breakage could be occurred because of the surgeon was not completely aligned with the screw, so the screwdriver was overstressed by applying a bending force directly on the four teeth.
Event or Problem Description
During surgery, one piece of the tip of the screwdriver was broken.The pieces fell into the patient and then the surgeon recovered all the fragments.The surgery was completed with the same screwdriver using three tips.No delay was reported, the surgery was completed successfully.

• Brand Name: SHOULDER GENERAL GLENOID POLYAXIAL SCREWDRIVER - NON-RETENTIVE
• Common Device Name: SURGICAL INSTRUMENT FOR SHOULDER SURGERIES
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8256601
• Report Number: 3005180920-2018-01100
• Device Sequence Number: 16658318
• Product Code: LXH
• UDI-Device Identifier: 07630971211902
• UDI-Public: 07630971211902
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/17/2019

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 Catalogue Number: 04.01.10.0284
• Device Lot Number: 1752863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/17/2019
• 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