MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI TEMPORARY SET SCREWDRIVER; SURGICAL INSTRUMENT FOR SPINE SURGERY

Catalog Number	03.75.10.0041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 01 july 2019: lot 1852846: (b)(4) items manufactured and released on 12-sep-2018.No anomalies found related to the problem.To date, no other similar events have been reported.Preliminary investigation performed by r&d spine project manager: the available information are not sufficient to determine the real root cause about this failure.It is assumed that the temporary set-screwdriver was accidentally stressed during previous surgeries and/or workshop activity, reaching the highest torsional load.Mechanical test have been performed on the instrument during the design validation activity to prove that the screwdriver is suitable for the intended use, as well as to carried out the expected failure mode when undergoing to the highest stress.
Event or Problem Description
During the primary spine surgery, and while placing the set cap into the tulip, the set screw driver broke.Fragments fell into the patient and were retrieved.There was a 1-minute delay and the surgeon used a backup driver the complete the case.The surgery was completed successfully.The set screw driver was from a loaner set.

• Brand Name: MUST MINI TEMPORARY SET SCREWDRIVER
• Common Device Name: SURGICAL INSTRUMENT FOR SPINE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8807561
• Report Number: 3005180920-2019-00587
• Device Sequence Number: 19382202
• Product Code: LXH
• UDI-Device Identifier: 07630971208711
• UDI-Public: 07630971208711
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 07/19/2019

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: 03.75.10.0041
• Device Lot Number: 1852846
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/19/2019
• 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