MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM GUIDEWIRE, BLUNT AND DISPOSABLE 1.37MM; MISC ORTHO SURGICAL INSTR

Model Number	286705200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
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 an unknown date in 2021 during an unknown procedure, the surgeon was tapping tough sclerotic bone over the guidewire.Both verse cannulated taps snapped when preparing the pilot hole.Fragments were generated and removed using dolphin nosed pliers.The procedure was successfully completed using an alternative tap.There was a surgical delay of fifteen (15) minutes.There was no patient consequence.This report is for one (1) viper system guidewire, blunt and disposable 1.37mm.This is report 3 of 3 for (b)(4).
Additional Manufacturer Narrative
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.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 GUIDEWIRE, BLUNT AND DISPOSABLE 1.37MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• 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: 13010501
• Report Number: 1526439-2021-02556
• Device Sequence Number: 20194271
• Product Code: LXH
• UDI-Device Identifier: 10705034213668
• UDI-Public: 10705034213668
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,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: 286705200
• Device Catalogue Number: 286705200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 12/15/2021
• 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: 5MM DOUBLE-LEAD TAP, CAN; 6MM DOUBLE-LEAD TAP, CAN; UNKNOWN SCREWS
• Patient Sex: Unknown