MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 SCREW EXT, MULTI PIECE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286725225
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
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.Reporter is a j&j sales representative.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, intraoperatively the instrument fractured at the welding seam when inserting the cage.No fragment remained in the patient.A second instrument was used for the final insertion of the cage.There was no significant delay and the procedure was completed successfully without any patient harm.This report is for one (1) viper 2 system multi-piece screw extension closed.This is report 2 of 2 for complaint (b)(4).

• Brand Name: VIPER2 SCREW EXT, MULTI PIECE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12749338
• Report Number: 1526439-2021-02315
• Device Sequence Number: 4489684
• Product Code: LXH
• UDI-Device Identifier: 10705034214320
• UDI-Public: (01)10705034214320
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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: 286725225
• Device Catalogue Number: 286725225
• Device Lot Number: MI30982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 10/10/2021
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2013
• 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
• Patient Sex: Unknown