MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME INSERTER SHAFT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 286750031

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: a review of the receiving inspection (ri) for viper prime inserter shaft was conducted identifying that lot number mf4332901 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 09 jan 2019 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 investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during a posterior spinal fusion procedure, before the surgery, it was confirmed that two screws and two inserter shafts could not be detached.Two screws were attached to each of the two inserter shafts for preparation according to the surgical plan.Since the stylet was not properly assembled, the surgeon tried to remove the screws once.When the surgeon tried to loosen the green knob of inserter shafts, it was too hard to remove the screw.Same for the other insert shaft and screw.The surgery was performed with other company¿s implants and instruments.The surgery was completed successfully without any surgical delay.After the surgery, sales rep confirmed that one of the two screws and inserter shafts replicated the same non-detachable situation.The other was not reproducible.Patient outcome is reported as stable.No further information is available.This report is for one (1) viper prime inserter shaft.This is report 3 of 5 for complaint (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that viper prime inserter shaft showed normal wear consistent with the device use which would not contribute to the complaint condition.The dimensional inspection was performed for the that viper prime inserter shaft.The functional test was performed with the mating device viper prime cfx xtab 7x45mm ti and was able assemble and disassemble.However, the green collar of the viper prime inserter shaft showed resistance during disassembly, probably contributing to the complaint condition.As part of depuy synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the green collar of viper prime inserter shaft showed resistance during disassembly, which could have contributed to the complained device interaction issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 the following drawing reflecting the current and manufacture revision was reviewed: viper prime inserter shaft assy.Viper prime inserter shaft.Dimensional inspection: checked outer diameter of the shaft per drawing: shaft diameter specification/measured: pass.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 INSERTER SHAFT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13018588
• MDR Text Key: 284120393
• Report Number: 1526439-2021-02571
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034507583
• UDI-Public: (01)10705034507583
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 286750031
• Device Catalogue Number: 286750031
• Device Lot Number: MF4332901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN HANDLES; VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME CFX XTAB 7X45MM TI