MAUDE Adverse Event Report: DEPUY SPINE INC VIPER 2 SYSTEM ROD HOLDER, ANGLED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286735100
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional 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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 or Problem Description
It was reported that in the middle of a spinal fusion procedure on (b)(6) 2022, while trying to load a viper rod onto a viper 2 rod holder, the rod would not fit or engage.Upon closer examination from the nurse, it appeared that there was a metal piece apart of the rod holders mechanism protruding and interfering.The nurse used a hospital instrument to move the protrusion and was able to load the rod as intended.The procedure was completed successfully after a surgical delay of 5 minutes.No further information is available.This report is for a viper 2 system rod holder, angled.This is report 1 of 1 for (b)(4).

• Brand Name: VIPER 2 SYSTEM ROD HOLDER, ANGLED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 15358585
• Report Number: 1526439-2022-01539
• Device Sequence Number: 13861943
• Product Code: LXH
• UDI-Device Identifier: 10705034214504
• UDI-Public: (01)10705034214504
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,Company Representative
• Initial 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
• Operator of Device: Health Professional
• Device Model Number: 286735100
• Device Catalogue Number: 286735100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 09/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - RODS: VIPER
• Patient Sex: Unknown