MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM LAG SCREW ROD STABILIZER 5.5; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	279704055
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional 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.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
It was reported that during a posterior lumbar fusion for degenerative disease on (b)(6) 2024, during the final fastening of the sai screw, it was not possible to insert the torque driver into the sai counter torque in question.The welded part of the sai counter torque in question was protruding, so the screwdriver could not be inserted.Since the final fastening was done by gripping the rod with a rod holder and applying torque, there were no problems.The surgery was completed successfully without any surgical delay.There was no patient consequence.
Additional 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.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device revealed that the sai counter torque was observed wear on the surface due to normal use.Additionally, part of what appears to be the weld that joins the base of the assembly with the tube is protruding.This condition can make it difficult to slide correctly with the mating device.However, the condition of fell apart cannot be confirmed due to the device does not come apart.Therefore, the reported condition can be partially confirmed.A definitive root cause could not be determined for the reported event.A dimensional inspection was performed and met specifications.A functional evaluation was unable to be performed due to the mating device was not returned.The overall complaint was confirmed as the observed condition of the sai counter torque would have 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) sai counter torque , was conducted identifying that lot number was pc3238089 released in one batch.Batch 1: lot qty of (b)(4) units were released on 30 mar 2016 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER SYSTEM LAG SCREW ROD STABILIZER 5.5
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 20169697
• Report Number: 1526439-2024-02306
• Device Sequence Number: 8249808
• Product Code: GEA
• UDI-Device Identifier: 10705034301242
• UDI-Public: (01)10705034301242(10)PC3238089
• 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,Followup

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: 279704055
• Device Lot Number: PC3238089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWDRIVERS; UNKNOWN SCREWS
• Patient Sex: Unknown