MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME INSERTER SHAFT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 286750031

Device Problems Device Slipped (1584); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

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

Event Date 07/07/2023

Event Type  malfunction  

Event Description

Device report from germany reports an event as follows: it was reported that on (b)(6) 2023, the hcp was found to have problems with detaching the screw from the screwdriver.Sometimes the screw is hard to detach, and sometimes the screw sits a bit loose on the screwdriver tip.The screwdrivers seem worn.There was no reported patient impact, no reported surgical delay.No further information is available.This report is for a viper prime inserter shaft.This is report 6 of 7 for (b)(4).

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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: 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.

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.A review of the receiving inspection (ri) for viper prime inserter shaft, was conducted identifying that lot number mf4440501 was released in one batch.Batch1: lot qty of (b)(6) units were released on jul 26, 2021 with no discrepancies.Supplier: (b)(4).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 product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the viper prime inserter shaft.The overall device appears to be in good condition with no signs of wear of the tip that could have contributed to the functional issues reported.A dimensional inspection was performed for the viper prime inserter shaft and met specifications.A functional test was unable to be performed since its mating device was not returned.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the viper prime inserter shaft was found to have no damage or defects.No definitive root cause could be determined.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.If information is obtained that was not available for this 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): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17415518
• MDR Text Key: 320510161
• Report Number: 1526439-2023-01393
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034507583
• UDI-Public: (01)10705034507583
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 286750031
• Device Lot Number: MF4440501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2021
• 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 SCREWS; VERSE POLY DRIVER, SHAFT; VERSE POLY DRIVER, SHAFT; VIPER PRIME INSERTER SHAFT; VIPER PRIME INSERTER SHAFT; VIPER PRIME INSERTER SHAFT