MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW POLYAXIAL REDUCTION PEDICLE SCREWDRIVER 2.0 CANNULAT; SURGICAL INSTRUMENT FOR SPINE

Catalog Number	03.51.10.0222
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 17 april 2019: lot 1753583: (b)(4) items manufactured and released on 15-jan-2018.No anomalies found related to the problem.To date, no similar event has been reported.Preliminary investigation performed by r&d (b)(4): from the picture enclosed is possible to see that the tip of the screwdriver, ref.(b)(4), lot 1753583, is broken.Based on the fracture lines, the mechanism of failure seems to be the application of a bending torsion load.Anyway, a deeper analysis can be performed during the visual inspection.
Event or Problem Description
Instrument tip breakage during spinal fixation surgery l2/l5 performed with myspine mc.The tap has been used.A partial broken piece was able to retrieve, but some were remained on the pedicle screw head.They were not able to retrieve, so the surgeon decided to fix the pedicle screws remaining some broken pieces.At that time since the polyaxial pedicle screw head was not able to move smoothly, the surgeon had to replace 2 rods with new ones.The pedicle screw head movement angular was restricted.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: brakeage of the tip during screw insertion.Breakage can occur in case of high insertion torque, typically related to large diameter screws (>7mm), long screws (>60mm) and/or hard bone (e.G.Sacral bone, sclerotic bone).In such cases, bone tapping is recommended in the surgical technique as well as in pbn spine-005-16.In this case, screw size and bone quality are not known.The tap was used.The instrument set always includes a second pedicle screwdriver, and another "simple" screwdriver (ref 03.51.10.0140 or equivalent) to complete the surgery in case of breakage.The tip material and geometry is proven to withstand up to 9nm torque, which is a significant force for a pedicle screw insertion (note, 9nm is also the final tightening torque for the setscrew, that needs a t-handle and a countertorque to be applied.) - the strength of the tip of the screwdriver is driven by the dimensions (hexalobe t20) and the material (aisi x15-tn or equivalent) which are comparable to predicate devices.Geometrical features are driven by the implant design and are equivalent to similar products in the market.The material is among the strongest materials for such application in terms of strength and hardness.

• Brand Name: PEDICLE SCREW POLYAXIAL REDUCTION PEDICLE SCREWDRIVER 2.0 CANNULAT
• Common Device Name: SURGICAL INSTRUMENT FOR SPINE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8527545
• Report Number: 3005180920-2019-00299
• Device Sequence Number: 1571225
• Product Code: LXH
• UDI-Device Identifier: 07630971230767
• UDI-Public: 07630971230767
• 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,Followup
• Report Date (Section B): 05/28/2019

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: 03.51.10.0222
• Device Lot Number: 1753583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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: 79 YR