MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM CANNULATED MONOAXIAL SCREW 5.5 X 6.0 X 40MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number	186717640
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent removal surgery due to breakage of the monoaxial screw.The implant was originally placed in the patient on (b)(6) 2017.It was found that the handle required for removal was not delivered before the procedure.The surgeon used a different unknown handle instead but the broken screw could not be removed as the handle did not reach the screw.The surgery was ended with the screw remaining in the patient.There is no further information available.This report is related to (b)(4).This report is for one (1) viper system cannulated monoaxial screw 5.5 x 6.0 x 40mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional procode: nkb, osh, mni, kwq, kwp.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j employee.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.

• Brand Name: VIPER SYSTEM CANNULATED MONOAXIAL SCREW 5.5 X 6.0 X 40MM
• Common Device Name: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13019766
• Report Number: 1526439-2021-02578
• Device Sequence Number: 11947386
• Product Code: MNH
• UDI-Device Identifier: 10705034123462
• UDI-Public: 10705034123462
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Operator of Device: Health Professional
• Device Model Number: 186717640
• Device Catalogue Number: 186717640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RATCHETING CMFT T-HANDLE 1/4"
• Patient Sex: Unknown