MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MIS PEDICLE SCREW MUST PEDICLE SCREWDRIVER - MIS HYBRID; SURGICAL INSTRUMENT FOR SPINE SURGERY

Catalog Number	03.52.10.0406
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 07 jun 2019 lot 1850171: (b)(4) items manufactured and released on 23-apr-2018.No anomalies found related to the problem.To date, no other similar events have been reported on this lot.Visual inspection performed by r&d project manager: the tip of the screwdriver torx t20 of the ref.03.52.10.0406, lot 1850171 is broken.The type of breakage is compatible with a bending/torsion of the screwdriver, maneuver that has to be avoided.By the description of the event, it seems that the bone quality of the patient (hard bone) can bring to very high torque application despite of the using of the tap before the screw insertion.The signs on the shaft on the opposite side of the lines of fracture confirm the failure mechanism mentioned above.The root cause of the breakage is probably the application of too high torque.
Event or Problem Description
Tlif surgery was performed at l4-s1.When the surgeon inserted the pedicle screw at right side of l5, he felt abnormal feelings.He discovered that the tip of the screwdriver was broken.The broken pieces of the screw driver remained in the pedicle screw tulip.The surgery was finished without retrieving broken pieces.Due to this event the surgery was prolonged about 20 minutes.The patient bone was very hard, so the taps were used before inserting the pedicle screw.Mis technique.

• Brand Name: MIS PEDICLE SCREW MUST PEDICLE SCREWDRIVER - MIS HYBRID
• 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: 8699970
• Report Number: 3005180920-2019-00464
• Device Sequence Number: 19400128
• Product Code: LXH
• UDI-Device Identifier: 07630971202542
• UDI-Public: 07630971202542
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/14/2019

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: 03.52.10.0406
• Device Lot Number: 1850171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/14/2019
• 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 Weight: 71