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

Catalog Number	286750031
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: h3, h6 investigation summary the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the star driver tip was slightly stripped.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.A complete functional test can not be performed without mating device.It is not possible to confirm though visual inspection the functionality issue reported.Therefore, the reported inability to retain mating device can not be confirmed.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the viper prime inserter shaft would have not contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): 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)(4) units were released on jul 26, 2021 with no discrepancies.Supplier: metal craft machine & engineering 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.
Event or Problem Description
It was reported that preoperatively it was mentioned that the screws cannot be attached to the instrument.There was no patient harm.Screw on the screwdriver could hardly be moved, so the screw could not be fitted.

• Brand Name: VIPER PRIME INSERTER SHAFT
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 22795874
• Report Number: 1526439-2025-00995
• Device Sequence Number: 8789301
• Product Code: NKB
• UDI-Device Identifier: 10705034507583
• UDI-Public: (01)10705034507583(10)MF4440501
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171570
• 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: Other Health Care Professional
• 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 Catalogue Number: 286750031
• Device Lot Number: MF4440501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown