MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP 6.35 TI POLY 6 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 179912640

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2022

Event Type  malfunction  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional device product codes: kwp, mnh, kwq, osh, nkb complainant part is not expected to be returned for manufacturer review/investigation.Part# 179912640.Lot # atgd83.(b)(4).No ncrs were generated during production.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2022 surgeon was removing a pedicle screw from a patient and the head of the screw broke off, leaving the screw shank in the pedicle of the patient.Surgeon was able to eventually remove the piece of the broken screw from the patient, however it did require 8-10 mins of added time.This report involves one expedium spine system polyaxial screw 6.35 x 6 x 40mm.This is report 1 of 1 for (b)(4).

• Brand Name: EXP 6.35 TI POLY 6 X 40MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle
• Manufacturer Contact: kate karberg ; chemin blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 15337614
• MDR Text Key: 305544317
• Report Number: 1526439-2022-01521
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034086460
• UDI-Public: 10705034086460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Model Number: 179912640
• Device Catalogue Number: 179912640
• Device Lot Number: ATGD83
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 68 KG