MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MIS PEDICLE SCREW Ø6 MM CANNULATED TAPERED TAP UNDERSIZED; SURGICAL INSTRUMENT FOR SPINE SURGERY

Catalog Number	03.51.10.0240
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 30 july 2019: lot 1852519: (b)(4) items manufactured and released on 09-oct-2018.No anomalies found related to the problem.To date 1 another similar event reported.
Event or Problem Description
During surgery the cannulated tip of the instrument partially broke.The fragment was not found in the surgery room.The fluoroscopy didn't show the presence of the piece in the patient.
Additional Manufacturer Narrative
On september 18th 2019 the instrument involved in the event returned.Visual inspection performed by r&d project manager: the threaded tips of the instruments is broken.The event can occurred due to wrong manoeuvre (e.G.High leverage applied during bone tapping, or change of direction of the hole during bone tapping) or wrong maintenance (e.G.Storage and shipping).The small instrument fragment was not found in the operating room neither in the patient using fluoroscopy.The bone tap, due to this damage, is no more functional (it cannot create the trajectory for screw insertion as required, according pedicle screw profile).Bone tap is a standard instrument for pedicle screw placement.The design and dimensions are driven by dimensions of the relevant screw.The material is stainless steel (aisi 431 or aisi 630) which is a standard material for such application.

• Brand Name: MIS PEDICLE SCREW Ø6 MM CANNULATED TAPERED TAP UNDERSIZED
• 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: 8924579
• Report Number: 3005180920-2019-00698
• Device Sequence Number: 19505107
• Product Code: LXH
• UDI-Device Identifier: 07630971230934
• UDI-Public: 07630971230934
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 10/18/2019

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: 03.51.10.0240
• Device Lot Number: 1852519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 10/18/2019
• 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: 18 YR