MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM

Catalog Number	03.52.323
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2018.Lot 1820933: 200 items manufactured and released on 03 october 2018.Expiration date: 2023-08-19.No anomalies found related to the problem.To date, 70 items of the same lot have been already sold without any similar reported event.Other device involved: pedicle screw must pedicle screwdriver - mis hybrid reference (b)(4).Lot 1755117: 15 items manufactured and released on 29 march 2018.No anomalies found related to the problem.To date, no similar reported event.Visual inspection performed the (b)(6) 2018 by r&d product manager.Pictures received with the complaint have been also considered.The first thread of the pedicle screw head (tulip) is damaged.The implant can still engage a pedicle screwdriver with some friction.Procedures and control methods have been established to ensure 100% verification of the correct assembling and coupling with the related instruments during final inspection before packaging of the implants.Therefore it can be excluded that the implant was already defective when the box was opened.Deformation/damage could have occurred due to handling e.G.Because of cross threading with the pedicle screwdriver.
Event or Problem Description
The nurse was not able to engage the pedicle screw with the screwdriver.After many attempts, debris was generated on the pedicle screw thread.The surgery was finished with the back up implant.No critical delay.The same screwdriver was able to engage with the back up implant.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8069031
• Report Number: 3005180920-2018-00897
• Device Sequence Number: 16567455
• Product Code: NKB
• UDI-Device Identifier: 07630030857584
• UDI-Public: 07630030857584
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141988
• 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): 11/14/2018

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 Expiration Date: 08/19/2023
• Device Catalogue Number: 03.52.323
• Device Lot Number: 1820933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/14/2018
• 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: 75 YR