MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 6X40; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	186727640
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.The device history record (dhr) of product code 186727640, lot 287544, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on september 23, 2020.A product investigation was completed: upon visual inspection, it was observed that head's threads are torn off.Functional test was performed on the device.Inner set screw was tried to place into screw.An attempt made to assemble both mating devices, it was not placed properly however it got stuck & unable to disassemble since the threads of both the devices set screw and screw were damaged.No dimensional inspection can be performed due to post-manufacturing damage.The relevant drawing was reviewed.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 or Problem Description
Device report from synthes (b)(6) reports an event as follows: the thread of the screw was turned off by the persuader of the viper system.The inner set screw could not find any thread to lock into.The screw and the inner were both replaced with new devices.The procedure was successfully completed with a ten (10) minute surgical delay.No fragments were generated.During the manufacturer investigation of the returned product it was noted that head's threads are torn off.This report is for a screw.This is report 1 of 2 for (b)(4).

• Brand Name: MIS TI CFX FEN POLY 6X40
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11215178
• Report Number: 1526439-2021-00173
• Device Sequence Number: 14418349
• Product Code: MNI
• UDI-Device Identifier: 10705034282558
• UDI-Public: (01)10705034282558
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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 Model Number: 186727640
• Device Catalogue Number: 186727640
• Device Lot Number: 287544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/22/2021
• Patient Sequence Number: 1