MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179704880
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the viper system wide lag screw implanted in the patient broke at the transition between the smooth and threaded portion of the screw.The original surgery took place in 2018.The patient underwent revision surgery on (b)(6) 2021.Upon removal, only the smooth part of the screw shank could be retrieved and the proximal threaded tip of the screw was left in the ilium.An iliac bolt was used to revise the construct.This report is for one (1) viper system polyaxial wide lag screw 5.5 8 x 80mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: event occurred on an unknown date in 2021.Additional procode: mnh, mni, kwp.The device was 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.
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.Visual inspection: the viper ti sai poly 8x80mm (p/n: 179704880, lot number: tbtww) was received at us cq.Visual inspection of the complaint device showed the threaded portion of the tip had broken off, and broken fragment was not returned.Also, scratches were observed all over the device, which is consistent with the device use and would not contribute to the complaint condition.However, the reported condition for embedded device could not be confirmed since no such evidence was provided.Device failure/defect identified? yes.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the overall complaint was confirmed as the threaded portion of the screw had broken off, but the reported condition could not be confirmed.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 exp 5.5 ti sai poly 8x80mm was conducted identifying that lot number tbtww was released in a single batch.Batch1: lot was released on may 15, 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.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 POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13003716
• Report Number: 1526439-2021-02546
• Device Sequence Number: 19887687
• Product Code: NKB
• UDI-Device Identifier: 10705034265728
• UDI-Public: 10705034265728
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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,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: 179704880
• Device Catalogue Number: 179704880
• Device Lot Number: TBTWW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 12/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2018
• 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 EXTRACTION INSTRUMENTS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown