MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFN XTB 6X45MM S; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	186760445S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procodes: kwp, kwq.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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.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 (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2020, the surgeon determined that the screw driver was no longer correctly placed into the screwdriver.When examining the screw (reclamping on the viper prime screwdriver), it was discovered that the screw saddle is no longer in the tulipe (broke away).The screw was being implanted into hard sclerotic bone.The viper prime screw was replaced.Procedure was successfully completed with no delay.There was no patient consequence.Concomitant devices: screwdriver (part: unknown, lot: unknown, quantity: unknown).This report is for a viper prime screw.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, h6: 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.
Event or Problem Description
Updated event description: concomitant device reported: viper prime cfxfn xtb 6x45mm s (part# 186760445s, lot# avcbky,, quantity 1).4.0 ply screw 3.5x12 (part# 102035112, lot# 254654, quantity 1).Ti 4.0x030 lor rod (part# 102064030, lot# tbxuc, quantity 1).Set screw (part# 102000000, lot# 238874, quantity 1).
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 product investigation was conducted: flow: damage.Visual inspection: the viper prime cfxfn xtb 6x45mm s (p/n: 186760445s, lot #: tbzct) was returned and received at us cq.Upon visual inspection, it was observed that all the three components of the assembly were disassembled/ fell apart.No other issues were identified with the returned device.The device failure/defect was identified.Dimensional inspection: a dimensional inspection was not performed on the returned device due to confirmed post manufacturing damage.Document/specification review: based on the date of manufacture of all relevant drawings, the current and manufactured revision of drawings were reviewed.The complaint was confirmed.The components of the assembly fell apart which could have resulted in the complaint condition.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the viper prime cfxfn xtb 6x45mm s (p/n: 186760445s, lot #: tbz ct).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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: the dhr of product code 186760445s, lot tbzct, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on august 13, 2019.Qty.150.The dhr was electronically reviewed.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 PRIME CFXFN XTB 6X45MM S
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10459415
• Report Number: 1526439-2020-01536
• Device Sequence Number: 2828120
• Product Code: NKB
• UDI-Device Identifier: 10705034530093
• UDI-Public: (01)10705034530093
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2020

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: 186760445S
• Device Catalogue Number: 186760445S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 09/24/2020; 10/20/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 10/13/2020; 10/22/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.0 PLY SCRW 3.5X12; SET SCREW; TI 4.0X030 LOR ROD; UNKNOWN SCREWDRIVERS; VIPER PRIME CFXFN XTB 6X45MM S