MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	286750100
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary the product was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that the viper prime torque handle exhibits signs of normal use.No cosmetic defects were observed over the surface.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was performed using torque meter.Drawing was used as source of specification.Torque handle is required to deliver 72-88 lb.In at intermediate setting.Actual measured values range from 80.21-136.90 lb.In.A device issue was identified resulting in over torquing.It is possible over torque lead to breakage of the mating viper prime set scrw insert used and returned under the complaint.The overall complaint was confirmed as the observed condition of the viper prime torque handle would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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 depuy synthes 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.Dimensional inspection: n/a.Device history a review of the receiving inspection (ri) for viper prime torque handle was conducted identifying that lot number gb125223 was released in one batch.Batch 1: lot qty of (b)(4) units were released on 15 feb 2020 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.
Event or Problem Description
It was reported that patient underwent posterior spinal fusion (l2-l5) on (b)(6) 2026.After l2-l5 3-segment lif (non-synthes), pps fixation of l2-l5 in the prone position, cement injection was planned craniocaudally.Procedure used viperprime screw, viperprime fenestrated screw, cement injection: l2: 1cc/r: 1.2cc, l5: 1cc.A metallic sound, different from the usual, rang out right before cutting the torque when fixing the set screw and final fixing was performed after screwing, cement injection, compression, rodding.The tip of the set screwdriver broke, and it remained in the body.It was not removed by the surgeon¿s decision.The surgery was completed successfully within thirty minutes surgical delay.The patient's condition after surgery was not confirmed.The patient has metal allergy, and the sales rep has checked the set screw driver¿s material and shared information with nurses and doctors.

• Brand Name: VIPER PRIME
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 25430840
• Report Number: 1526439-2026-00674
• Device Sequence Number: 10322149
• Product Code: LXH
• UDI-Device Identifier: 10705034507750
• UDI-Public: (01)10705034507750(10)GB125223
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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: 286750100
• Device Lot Number: GB125223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2020
• 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 Age: 64 YR
• Patient Sex: Female