MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW POLYAXIAL SCREWDRIVER SLIM; SURGICAL INSTRUMENT FOR SPINE SURGERY

Catalog Number	03.51.10.0136
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 08 september 2017: lot 1410893aaa: (b)(4) items manufactured and released on 11 august 2016.No anomalies found related to the problem.To date, another similar event has been reported on items of the same lot (complaint (b)(4)).Visual inspection performed by r&d (b)(4): breakage of the screwdriver 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 this case, screw size, bone quality and surgical procedure are not known.The tip material and geometry is proven to withstand up to 9nm torque, which is a significant force for a pedicle screw insertion.The strength of the tip of the screwdriver is driven by the dimensions (hexalobe t20) and the material (aisi 420 mod) 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.After the breakage, it was not possible to remove the broken portion of the tip from the screw, probably due to the fact that the metal fragment was deeper respect to the inlay upper surface, and hence difficult to be reached.On the other hand, probably due to the absence of fragment protrusion from the inlay, the surgeon was able to insert and lock the rod without any additional issues or compromised functionality.
Event or Problem Description
During the surgery, the tip of the screwdriver got broken.The surgeon inserted a screw and then one of the "wings" of the tip of the screwdriver got broken.The surgery ended successfully, but the surgeon wasn't able to remove the broken tip of the instrument out of the screw.The broken tip still sticks in the screw and is implanted in the patient.But it couldn't harm the patient, because it's locked with the rod and set screw.Another medacta screwdriver has been used to finish the surgery.

• Brand Name: PEDICLE SCREW POLYAXIAL SCREWDRIVER SLIM
• Common Device Name: SURGICAL INSTRUMENT FOR SPINE SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8577869
• Report Number: 3005180920-2019-00336
• Device Sequence Number: 2346051
• Product Code: LXH
• UDI-Device Identifier: 07630971201620
• UDI-Public: 07630971201620
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/03/2019

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: 03.51.10.0136
• Device Lot Number: 1410893AAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 05/03/2019
• 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: 75 YR
• Patient Weight: 92