MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW REDUCTION CANNULATED 7X45; SPINE REDUCTION CANNULATED PEDICLE SCREW

Catalog Number	03.52.731
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 07 march 2019: lot 1820182: (b)(4).No anomalies found related to the problem.To date, two similar events have already been reported on this lot (b)(4).
Event or Problem Description
Spinal fixation performed at l3-s2ai and reduction screws were used between l3-l5.After the insertion of reduction screw at l3 left side, it was hard to disengage the driver from pedicle screw head.Finally one tab broke.The surgeon replaced the broken screw with a new one with the same reference.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: the reduction head of the pedicle screw 03.52.731, lot 1820182, has one of the tabs broken in the dedicated area.The dimensions of the head are according to the specification.The breakage point is in the dedicated breaking area.The assembling/disassembling with the related polyaxial screwdriver (ref.03.51.10.0204 lot 1550541a) is smooth and correct.After the assembling, the screw is firmly fixed even without one of the tab.The potential root cause of the event could be the application of a lateral force on the tab by the polyaxial screwdriver.This could happen only if the polyaxial screwdriver was disengaged by tulip hed thread and then bent.

• Brand Name: PEDICLE SCREW REDUCTION CANNULATED 7X45
• Common Device Name: SPINE REDUCTION CANNULATED PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8403889
• Report Number: 3005180920-2019-00136
• Device Sequence Number: 16212584
• Product Code: NKB
• UDI-Device Identifier: 07630030847226
• UDI-Public: 07630030847226
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153664
• 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): 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2023
• Device Catalogue Number: 03.52.731
• Device Lot Number: 1820182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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: 72 YR