MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MODIFIED INSTRUMENT DRIVER, SHORT T20; DRIVER, PROSTHESIS

Model Number	698337505
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 while using the screwdriver shaft on power, to advance a pedicle screw into the pelvis the tip broke in the shaft of the screw.The screw was removed which had the tip of the screwdriver in the shaft of the screw.Another screw was placed with no issue using the 2nd short screwdriver on power again, to advance the screw and it was noted that the tip was burred.The surgery was completed successfully with no surgical delay.This report is for one (1) modified instrument driver, short t20.This is report 2 of 2 for (b)(4).

• Brand Name: MODIFIED INSTRUMENT DRIVER, SHORT T20
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12481814
• Report Number: 1526439-2021-02026
• Device Sequence Number: 14415081
• Product Code: HWR
• UDI-Device Identifier: 10705034377261
• UDI-Public: 10705034377261
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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: 698337505
• Device Catalogue Number: 698337505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MOD T20 DRIVER SHORT; UNKNOWN SCREWS