MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW TWO-STEP REDUCER ENHANCED; SURGICAL INSTRUMENT FOR SPINE

Catalog Number	03.51.10.0182
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection performed october the 30th, 2018 by the r&d project manager: one out of the four retaining pins (interface to the implant - pedicle screw head) are missing, due to failure of the welding.The cause of pin breakage can be excessive stress related to excessive reduction force applied and/or other forces (e.G.Lateral bending), or existing damage/deformation of the pin from a previous surgery.The instrument set includes backup instruments.Batch review performed on november 6, 2018: lot 1850157: (b)(4) items manufactured and released on 27 june 2018.No anomalies found related to the issue.To date, no similar event on the same lot has been registered.Additional components involved: pedicle screw 03.50.031 pedicle screw 7x45, lot 1820670: 150 items manufactured and released on 30 august 2017.Expiration date: 2023-08-19.No anomalies found related to the problem.To date,(b)(4) items of the same lot have been already sold without any similar reported event.Pedicle screw 03.50.031 pedicle screw 7x45, lot.1820671: 150 items manufactured and released on 7 august 2018.Expiration date: 24.07.2023-07-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event (3 items involved).
Event or Problem Description
During surgery at l3-s1, the surgeon tried to insert the 6 pedicle screws with the two-step reducer enhanced.He was able to insert only 1 set screw and then the pin of the tip broke during the insertion at l4.The surgeon discovered the broken piece during the surgery.The two-step reducer broke while the surgeon was tightening either lot 1820670 or 1820671.No debris has fallen into the patient, the surgery has been completed with a back-up instrument.Because of this issue, the surgery was prolonged of 15 minutes.

• Brand Name: PEDICLE SCREW TWO-STEP REDUCER ENHANCED
• 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: 8041553
• Report Number: 3005180920-2018-00861
• Device Sequence Number: 1435258
• Product Code: LXH
• UDI-Device Identifier: 07630971226418
• UDI-Public: 7630971226418
• 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): 11/06/2018

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: 03.51.10.0182
• Device Lot Number: 1850157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 11/06/2018
• 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
• Patient Age: 74 YR