MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER UNI SCREW 5X35MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186720535
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part returned for manufacturer review/investigation.Reporter is a j&j employee.(b)(4).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 europe reports an event in (b)(6) as follows: it was reported that uniplanar screws were removed from the patient that found to be slightly bent at collar level, it was perpendicular from the natural screwhead axis.It was also important to note: the ablation of these screws has no relationship, nor reasons, with the bending issue announced in this complaint.This report is for one (1) viper system cannulated uniplanar screw 5.5 x 5.0 x 35mm.This report is 1 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.H3, h6: a review of the receiving inspection (ri) for viper uni screw 5x35mm ti was conducted identifying that lot number: rl271260 was released in a single batch.Batch1: lot qty of (b)(4) units were released on september 5, 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Visual inspection: the viper uni screw 5x35mm ti (p/n: 186720535, lot number: rl271260) was received at us customer quality (cq).Visual inspection of the complaint device showed the shaft of the screw was bent perpendicular to the rotation axis.The screw also had an unknown white foreign material present.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the shaft of the screw was bent perpendicular to the rotation axis.The screw also had an unknown white foreign material present.No definitive root cause could be determined based on the provided information.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.
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.H3, h4, h6- the viper uni screw 5x35mm ti (p/n: 186720535, lot number: rl271260) was received at us cq.Visual inspection of the complaint device showed the shaft of the screw was bent perpendicular to the rotation axis.The screw also had an unknown white foreign material present.This complaint is confirmed as the shaft of the screw was bent perpendicular to the rotation axis.The screw also had an unknown white foreign material present.No definitive root cause could be determined based on the provided information.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 history lot = a review of the receiving inspection (ri) for viper uni screw 5x35mm ti was conducted identifying that lot number rl271260 was released in a single batch.Batch1: lot qty of units were released on 05 sep 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.,a review of the receiving inspection (ri) for viper uni screw 5x35mm ti was conducted identifying that lot number rl271260 was released in a single batch.Batch1: lot qty of units were released on 05 sep 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review = the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.,the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 UNI SCREW 5X35MM TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11655791
• Report Number: 1526439-2021-00704
• Device Sequence Number: 11640694
• Product Code: NKB
• UDI-Device Identifier: 10705034125619
• UDI-Public: (01)10705034125619
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/16/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 186720535
• Device Catalogue Number: 186720535
• Device Lot Number: RL271260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/15/2021; 05/19/2021; 10/13/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/11/2021; 05/20/2021; 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; VIPER UNI SCREW 5X30MM TI; VIPER UNI SCREW 5X35MM TI; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; VIPER UNI SCREW 5X30MM TI; VIPER UNI SCREW 5X35MM TI
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR