MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	186770340S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: investigation summary: the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the viper prime cfx xtab 7x40mm ti had broken across the head component.The broken piece was not returned.No other issues were identified.The dimensional inspection could not be performed due to post manufacturing damage.The observed condition of the viper prime cfx xtab 7x40mm ti was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.A functional test could not be performed as the mating set screw in question was not returned for evaluation.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the viper prime cfx xtab 7x40mm ti was observed to have a broken head component.While no definitive root cause could be determined from the available information, it is probable that the concerned head component of the viper prime cfx xtab 7x40mm ti was broken due to the exposure to excessive/unintended forces.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.Drawing/specifications reviewed? drawings reflecting the current and manufactured revisions were reviewed: no issues device history: a manufacturing record evaluation was performed for the finished device product code: 186770340s.Lot number: tbaevl.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 30.04.2021.Qty: 349.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 a spinal fusion (l3-5) for treating burst fracture occurred on (b)(6) 2022.The surgeon did not succeed in final setscrew tightening at l4 right.The procedure was completed with a replacement which resulted in less than 30-minute surgical delay.Concomitant device reported: unknown tightener (part# unknown, lot# unknown, quantity unknown).This is report 1 of 1 for (b)(4).This report is for viper prime screw.

• Brand Name: VIPER PRIME CFX X-TAB POLYAXIAL SCREW 5.5 7 X 40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14162366
• Report Number: 1526439-2022-00593
• Device Sequence Number: 5795323
• Product Code: NKB
• UDI-Device Identifier: 10705034530178
• UDI-Public: (01)10705034530178
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173095
• 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

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: 186770340S
• Device Catalogue Number: 186770340S
• Device Lot Number: TBAEVL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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 TIGHTENER
• Patient Sex: Unknown