MAUDE Adverse Event Report: DEPUY SPINE INC VIPER 2 SYSTEM T-HANDLE, RATCHETING AND CANNULATED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286715350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that on (b)(6) 2021, during an unknown procedure the ratcheting mechanism was not working properly.The handle was broken and it was passed off the field.The handle was removed from the sterile field and tagged as broken.There was no surgical delay.There were no patient consequences.The procedure was successfully completed.This report is for one (1) viper 2 system t-handle, ratcheting and cannulated.This is report 1 of 1 for (b)(4).

• Brand Name: VIPER 2 SYSTEM T-HANDLE, RATCHETING AND CANNULATED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11733443
• Report Number: 1526439-2021-00806
• Device Sequence Number: 11660598
• Product Code: LXH
• UDI-Device Identifier: 10705034214030
• UDI-Public: 10705034214030
• 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): 04/01/2021

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: 286715350
• Device Catalogue Number: 286715350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1