MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 FINAL TIGHTENER HANDLE,; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	286745500
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient underwent a fusion surgery (t11-l2) on (b)(6) 2024.During the final fastening of the t12 set screw, the tip of the screwdriver shaft broke off and was stuck in the set screw and could not be removed.The other set screws were final fastened using another torque handle and screwdriver, and surgery was completed successfully without any surgical delay.The surgeon mentioned that the final fastening torque was not easy to apply and that the tip of the screwdriver shaft broke off when he tightened it with a lot of force.He also thought that the setscrew would not come loose because he had tightened it considerably.Therefore, follow-up observation is planned.This report is for a viper2 final tightener handle.
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.Added: b5, d4 (lot) and d10.Corrected: d4 (primary udi number).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
Additional information received states that the patient was stable and no other medical intervention was required.
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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
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.Visual inspection of the returned device revealed there was no broken condition observed.And with information currently available the reported condition remains unconfirmed.Furthermore, the handle was observed damaged by scratches and color was fading out due to this condition.This condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was performed with mating device returned and assembled as intended.The overall complaint was not confirmed as the observed condition of the viper2 final tightener handle, would have not contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.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 lot : a review of the receiving inspection (ri) for viper2 final tightener handle,, was conducted identifying that lot number gb70863 was released in one batch.Batch1: lot qty of (b)(4) units were released on jan 4, 2016 with no discrepancies.Supplier : (b)(4).Device history review : 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 report, a follow-up report will be filed as appropriate.

• Brand Name: VIPER2 FINAL TIGHTENER HANDLE,
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 20283958
• Report Number: 1526439-2024-02582
• Device Sequence Number: 18126283
• Product Code: LXH
• UDI-Device Identifier: 10705034214863
• UDI-Public: (01)10705034214863(10)GB70863
• 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,Followup,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: 286745500
• Device Lot Number: GB70863
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 10/16/2024; 10/23/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/10/2024; 10/18/2024; 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2016
• 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 LOCKING/SET SCREWS; VIPER2 FINAL TIGHTENER DRIVER
• Patient Sex: Unknown