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

Catalog Number	03.51.10.0222
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 20 november 2018: lot 1852516: (b)(4) items manufactured and released on 21-sep-2018.No anomalies found related to the problem.To date, no similar event has been reported for this lot.Visual inspection performed by r&d project manager: breakage 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 (b)(4).In this case, a screw ø7mm was inserted.Based on the information collected the surgeon the tap.The instrument set always includes a second pedicle screwdriver, and another "simple" screwdriver (ref (b)(4) 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.
Event or Problem Description
[lumbar fixation l4 - l5] during the insertion of a screw, the tip of the screwdriver broke.The operation was continued normally with another screwdriver and it was successfully finished without any delay or any additional problems.Screw involved: 7mm wide and 45mm long.The tap was used.Bone quality: normal.The broken tip was retrieved.

• Brand Name: POLYAXIAL REDUCTION PEDICLE SCREWDRIVER 2.0 CANNULATED
• 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: 8089809
• Report Number: 3005180920-2018-00925
• Device Sequence Number: 2178907
• Product Code: LXH
• UDI-Device Identifier: 07630971230767
• UDI-Public: 7630971230767
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2018

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: 1852516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/20/2018
• 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