MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186731745
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional device product codes: mni, kwp, kwq, and mnh.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.(b)(4).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 japan as follows: it was reported that on (b)(6) 2022, during a revision for a plif procedures (l3) for treating asd.After a screw (6.0 mm in diameter) was removed from the lesion, a replacement screw was prepared.The screw did not advance further against the much-hardened bone.When the surgeon forced the screw with the screwdriver, its tip broke off.The procedure was completed less than 30-minute surgical delay.This report involves one (1) viper system cortical fix polyaxial screw 5.5 7 x 45mm.This is report 2 of 2 for (b)(4).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d3, d9.H3, h4, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.H6: health effect - clinical code.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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a manufacturing record evaluation was performed for the finished device product code: 186731745.Lot number: 338340.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 24/03/2022.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the 5.5 ti cort fix 7x45mm.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test to assess the will not seat/advance condition can not be conducted since the allegation is related to bone as part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the 5.5 ti cort fix 7x45mm was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety 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.H6: health effect - clinical code.

• Brand Name: VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15312796
• Report Number: 1526439-2022-01491
• Device Sequence Number: 17724940
• Product Code: NKB
• UDI-Device Identifier: 10705034352015
• UDI-Public: 10705034352015
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110216
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186731745
• Device Catalogue Number: 186731745
• Device Lot Number: 338340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 10/14/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 10/11/2022; 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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: EXP A QUICKCONNECT SCREWDRIVER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown