MAUDE Adverse Event Report: DEPUY SPINE INC VIPER UNI SCREW 5X35MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186720535
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: kwp; kwq; mnh; mni; osh.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, it has been determined that no corrective and 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, while doing the final lock, after the derogation maneuver, the surgeon found that the rod was not tightly blocked into the uniplanar screw heads.This in comparison with the upper and lower poly axial screws with the fixation to the rod was very solid.With the uniplanar screws, one could clearly see an unexpected medio-lateral movement / degree of freedom despite an ad-hoc tightening with the torque handle.Procedure was completed successfully without any surgical delay.Concomitant device reported: unknown torque device (part # unknown, lot # unknown, quantity unknown).This complaint involves four (4) devices.This report is for (1) viper uni screw 5 x 35mm ti.This report is 3 of 4 for (b)(4).

• Brand Name: VIPER UNI SCREW 5X35MM TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13014268
• Report Number: 1526439-2021-02563
• Device Sequence Number: 1894272
• Product Code: NKB
• UDI-Device Identifier: 10705034125619
• UDI-Public: 10705034125619
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160904
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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: 186720535
• Device Catalogue Number: 186720535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN TORQUE DEVICES; VIPER UNI SCREW 5X35MM TI; VIPER UNI SCREW 5X35MM TI; VIPER2 STRAIGHT ROD300MM, COCR
• Patient Sex: Unknown