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

Model Number	03.52.323
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 24 september 2018: lot 1820885: (b)(4) items manufactured and released on 28 june 2018.Expiration date: 2023-06-06.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.Preliminary investigation performed by r&d project manager on sep 26, 2018: involved devices are not available and pictures are not provided.However, based on the description of the event, the following can be assumed.The difficulty to engage the set screw might be due to wrong engagement or misalignment of the percutaneous tower (03.52.10.0521) to the tulip, since the perc.Towers drive and orient the set screw, and after they removed and repositioned the tower, the set screw could be engaged.Wrong engagement/misalignment of the tower might be caused by deformation/damage of the same (potentially occurred in a previous surgery) or misuse of the tower itself or of the auxiliary instruments (loading station, engage handle) by the surgeon/nurse.
Event or Problem Description
The surgeon was not able to tighten the set screw into the pedicle screw tulip at l5 even though the he used with the reducer.He tried to remove the rod and insert the new set screw, but he was not able to tighten the new set screw as well.Disassembling the percutaneous tower and re-trying again he was able to tighten the second set screw.Due to this event the surgery was prolonged about 1 hour.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA SWITZERLAND; gewerbestrasse 3; frauenfeld, switzerland 8500 ; SZ 8500
• MDR Report Key: 7918477
• Report Number: 3005180920-2018-00733
• Device Sequence Number: 11153042
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2018

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: 06/06/2023
• Device Model Number: 03.52.323
• Device Lot Number: 1820885
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/28/2018
• 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: 86 YR
• Patient Weight: 53