MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST LT 15MM SHORT - PEDICLE SCREW Ø5X30 CANN; SPINE PEDICLE SCREW

Model Number 03.57.012

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/22/2022

Event Type  malfunction  

Event Description

The pedicle screw came off from the vertebral body when the rod was inserted into the screw tabs.No new screws were inserted into the vertebral body at this level, and fixation was performed only with screws and rods placed at another level.After inserting the rod, the final fastening was performed with the set screw.When an attempt was made to remove the rod from the inserter, the locking mechanism (handle for gripping the rod) of the instrument was stuck and could not be removed.It was forcefully unlocked with pliers.Another rod was then used and fastened with the set screw, when trying to remove the rod from the inserter the rod could not be removed and the gripping mechanism of the instrument broke.The part broken remained in the patient body.The surgery was completed successfully in 3.5 hours with 30 minutes of delay.

Manufacturer Narrative

Batch review performed on 27 december 2022: lot 2220315: (b)(4).Expiration date: 2027-06-13.No anomalies found related to the problem.(b)(4).Additional devices involved batch review performed on 27 december 2022: mis pedicle screw 03.52.10.0005 rod inserter bent shaft type 1 lot 1856905: (b)(4).No anomalies found related to the problem.To date, no other similar events have been reported on the same lot.Lot 2157010: (b)(4).No anomalies found related to the problem.To date, no other similar events have been reported on the same lot.Investigation performed by medacta spine r&d project manager: after rod insertion, it was impossible to remove one of the rod inserter by hands since the handle was blocked.It is not possible to clearly define the root cause of the failure, additional analysis will be done as the part arrives in medacta the other od inserter broke during the maneuvers to remove them, the welding broke on one of them.The fragment remained in the patient's body.Further investigations will be done as the part arrives in medacta.It is not possible to clearly define why the screw got loose and exited the vertebral body, further analysis will be done as the part arrives in medacta.

Manufacturer Narrative

Visual inspection performed bz r&d project manager during visual inspection, all devices reported in the complaint have been analyzed.The pedicle screw has been tested in sawbones block and it has been possible to perform final fixation without pullout.The root cause of the pullout is probably related to bone quality.Rod inserter lot.1856905; the release knob of the rod inserter is stuck, even after lubrication it was not possible to move it.A possible root cause may be excessive flexional force applied to the shaft.Rod inserter lot.2157010; tip of the instrument is broken and completely missing, because of failure of the welding.A possible root cause may be excessive flexional force applied to the shaft.

• Brand Name: MUST LT 15MM SHORT - PEDICLE SCREW Ø5X30 CANN
• Type of Device: SPINE PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16204617
• MDR Text Key: 308889280
• Report Number: 3005180920-2022-01014
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630971278295
• UDI-Public: 07630971278295
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K203482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.57.012
• Device Catalogue Number: 03.57.012
• Device Lot Number: 2220315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian