MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 T20 HEXLOBE DRIVER SHAF; DRIVER, PROSTHESIS

Model Number	286725020
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
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.Event occurred on an unknown date in 2021.Complainant part is not expected to be returned for manufacturer review/investigation.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
It was reported that on an unknown date during an anterior/posterior lumbar fusion procedure, , one (1) viper universal poly driver was broken, and two (2) t20 driver shafts were stripped.The surgeon was placing unknown screws in the patient when two (2) poly screwdriver shafts tips broke off.He then attempted to use the viper2 t20 hexlobe driver and t20 screwdriver shaft which both stripped.He advanced using the viper universal poly driver and the tip of the driver was found to be broken on the back table after it was taken out.There were no fragments generated.There was no patient consequence or surgical delay.The procedure was successfully completed.This report is for one (1) viper2 t20 hexlobe driver shaft.This is report 1 of 5 for (b)(4).

• Brand Name: VIPER2 T20 HEXLOBE DRIVER SHAF
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12665928
• Report Number: 1526439-2021-02220
• Device Sequence Number: 16439358
• Product Code: HWR
• UDI-Device Identifier: 10705034214290
• UDI-Public: 10705034214290
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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: 286725020
• Device Catalogue Number: 286725020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/20/2021
• 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: POLY SCW DRIVER SHAFT, CANNULTD; POLY SCW DRIVER SHAFT, CANNULTD; T20 SCREWDRIVER SHAFT; UNKNOWN AWLS; UNKNOWN SCREWS; VIPER UNIVERSAL POLY DRIVER