MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 55MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	186727755
Medical Device Problem Codes	Break (1069); Device Slipped (1584)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: pml.Reporter is a synthes employee.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 an unknown date that the patient experienced post-op screw loosening.On (b)(6) 2020 the patient underwent revision spondylodesis l5s1 surgery for pseudarthrosis and screw loosening s1.When unscrewing the screw, it was noticed that the anterior part of the screw had broken off.No fragments were generated.There was no surgical delay.The procedure was completed successfully.There was no reported consequence to the patient; however, part of the implant remains in the patient.Concomitant devices reported: rods (part number unknown, lot unknown, quantity unknown), setscrews (part number unknown, lot unknown, quantity unknown).This report involves one (1) viper system fenestrated cortical fix polyaxial screw 5.5 x 7 x 55mm.This is report 1 of 1 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, h4, h6: the dhr of product code 186727755, lot 228738, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on january 8, 2019.Qty.(b)(4).The dhr was electronically reviewed.Visual inspection: visual inspection performed at customer quality (cq) showed the implant broken at the distal tip.No other issues were identified.A device failure was identified.Functional test: the screw head was able to move freely with minimal resistance and nothing appeared to be loose and therefore the complaint condition of loose could not be confirmed.Dimensional inspection: distal tip ø: 6.85 +/- 0.1 mm.Measured dimensions: ø (near broken spot): conforming.Device used: om141p.Document/specification review: the following drawings were reviewed: viper cortical fix fenestrated screw assembly.Viper cortical fix fenestrated screw shank.Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: no definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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.
Event or Problem Description
The broken tip of the screw remains in the patient.

• Brand Name: VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 55MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11028275
• Report Number: 1526439-2020-02415
• Device Sequence Number: 10929786
• Product Code: MNI
• UDI-Device Identifier: 10705034282695
• UDI-Public: (01)10705034282695
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: 186727755
• Device Catalogue Number: 186727755
• Device Lot Number: 228738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/15/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR