MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI SOLID CERVICAL DRILL BIT AO CONN. Ø3.5X 10-24 SHORT; SURGICAL INSTRUMENT FOR SPINE SURGERY

Catalog Number	03.75.10.0014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 08.July.2019: lot 1853453: (b)(4) items manufactured and released on 16-nov-2018.No anomalies found related to the problem.To date, no other similar events have been reported.Visual inspection performed by medacta spine r&d project manager: based on the event description, it is not clear whether the drill seized up in the drill guide before breaking off in the patient.Mostly, brakeage of small drill-bit is due to a lateral displacement while the tip of the drill-bit is still in the bone.In this circumstances, the lateral displacement generates a shear forces that stress the smallest critical section.Visual inspection confirmed that the failure occurs in the minimal small cross section of the tip.Preliminary investigation and visual inspection were performed on the (b)(6) 2019.
Event or Problem Description
Short drill bit broke inside the patient, top of drill bit was in the patient's t1 bone.It had to be removed with surgical pliers.The surgery was completed successfully.

• Brand Name: MUST MINI SOLID CERVICAL DRILL BIT AO CONN. Ø3.5X 10-24 SHORT
• 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: 8814971
• Report Number: 3005180920-2019-00591
• Device Sequence Number: 16921546
• Product Code: LXH
• UDI-Device Identifier: 07630971208506
• UDI-Public: 07630971208506
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/23/2019

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: 03.75.10.0014
• Device Lot Number: 1853453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2019
• Initial Report FDA Received Date: 07/23/2019
• 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: 73 YR