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

Catalog Number	03.51.10.0240
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 23 april 2019: lot 1850164: (b)(4) items manufactured and released on 13-apr-2018.No anomalies found related to the problem.To date, no similar event has been reported on this lot.Additional instrument involved: mis pedicle screw 03.51.10.0240 ø6 mm cannulated tapered tap undersized, lot 1852519: (b)(4) items manufactured and released on 20-sep-2018.No anomalies found related to the problem.To date, no similar event has been reported on this lot.Visual inspection performed by r&d (b)(4): the threaded tips of the instruments is broken for both the references and lots.The event can be 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 issue was not detected during the surgery; it was observed after sterilization and shipment from hospital to the branch.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.
Event or Problem Description
Tip breakage of two cannulated tapered taps undersized when the surgeon was tapping at l4/5.The patient bone was hard.The tips remained in the patient but deep enough, the pedicle screws were inserted with no problem of impingement.30 minutes of delay.

• Brand Name: MIS PEDICLE SCREW Ø6 MM CANNULATED TAPERED TAP UNDERSIZED
• 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: 8555119
• Report Number: 3005180920-2019-00314
• Device Sequence Number: 11172537
• Product Code: LXH
• UDI-Device Identifier: 07630971230934
• UDI-Public: 07630971230934
• 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): 04/26/2019

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: 1850164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/26/2019
• 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