MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X45MM

Model Number	03.52.338
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 december 2019.Lot 1720377: (b)(4) items manufactured and released on 01-feb-2018.Expiration date: 2023-01-14.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.Clinical evaluation performed by medical director: 1,5 years after posterior lumbar fusion on a heavy patient, one of the pedicle screws is found broken and replaced few days later.The fracture of the screw did not hinder bone fusion, which took place satisfactorily.As the pedicle screws are temporary devices, it is possible that they may suffer fatigue fracture if, for example, bone fusion is delayed, or if it takes place in a situation that stresses the screw at long term.The damage on the outside of the screw thread is unclear: it may have been originated by removal procedure, but this is not written in the report.Also, the need to replace the screw if bone fusion was already successfully achieved is unclear.
Event or Problem Description
Primary surgery was performed at l5-s plif on (b)(6) 2018.The surgeon discovered the pedicle screw was broken at the left side of s1 in x-ray on december 9.Revision surgery was performed on (b)(6).The surgeon replaced with the new pedicle screw 8x50mm and performed the additional tlif surgery.The surgery finished successfully.It was unknown when the pedicle screw broke.The surgeon noticed the pedicle screw broke and continued the follow up until the revision surgery.The surgeon expressed an opinion that the pedicle screws seems to have strong force because the patient weight was (b)(6).
Additional Manufacturer Narrative
Device was returned on (b)(6) 2020.Preliminary investigation performed by r&d project manager from the pictures attached to the complaint, the pedicle screw 03.52.338, lot 1720377, is broken below the screw head before the thread starting.The root cause of the breakage is not clearly identified.A potential root cause could be the application of a very high load on the level.The lot involved (1720377) has no nc.A deeper analysis of the implant can be performed during the visual inspection.Preliminary investigation performed on (b)(6) 2020.Visual inspection performed by r&d project manager the pedicle screw received (ref.03.52.338 lot.1720377) is broken.There are no ncs in the route card of the lot 1720377.By the pictures enclosed in the complaint and by the visual inspection, it's possible to state that the root cause of the event is probably due to the application of a torsion bending force on the screw.As expressed also by the surgeon the force could be probably due also by the patient weight (105 kg).In addition to that the screw is in one of the most critical area in term of the discharging of force (s1).Visual inspection performed on (b)(6) 2020.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X45MM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9563986
• Report Number: 3005180920-2019-01116
• Device Sequence Number: 14002615
• Product Code: NKB
• UDI-Device Identifier: 07630030857768
• UDI-Public: 07630030857768
• 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
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2023
• Device Model Number: 03.52.338
• Device Catalogue Number: 03.52.338
• Device Lot Number: 1720377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 03/16/2020
• 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: Required Intervention
• Patient Weight: 105