MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME SET SCRW INSERT; SCREWDRIVER

Catalog Number	286750070
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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.
Event or Problem Description
It was reported that this was a posterior fusion (t11-l3) for ovf on (b)(6) 2024.When the final tightening of a screw was performed, the torque wrench would normally idle the handle after a certain torque is applied, but the handle did not get idled, and the screwdriver became damaged.The surgery was completed successfully with no surgical delay.No further information is available.
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 device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial report, a follow-up report 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.H11 additional narrative: h3, h6: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the viper prime set scrw insert tip is broken confirming the allegation, the remaining pieces were not returned for evaluation, the fracture surface was examined, and no damage related to material issues was observed.As no x-rays were provided or no broken material was seen in the mating device the embedded allegation cannot be confirmed.A dimensional inspection was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the viper prime set scrw insert 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.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 viper prime set scrw insert, was conducted identifying that lot number mf4542210 was released in three batches.Batch1: lot qty of (b)(4) units were released on may 19, 2023, with no discrepancies.Batch2: lot qty of (b)(4) units were released on may 19, 2023, with no discrepancies.Batch3: lot qty of (b)(4) units were released on aug 3, 2023, 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.

• Brand Name: VIPER PRIME SET SCRW INSERT
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 50461 west pontiac trail; wixom, MI 48393 ; 3035526892
• MDR Report Key: 20762395
• Report Number: 1526439-2024-02869
• Device Sequence Number: 18514957
• Product Code: HXX
• UDI-Device Identifier: 10705034507705
• UDI-Public: (01)10705034507705(10)MF4542210
• 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

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: 286750070
• Device Lot Number: MF4542210
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 01/30/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/23/2024; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• 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: VIPER PRIME TORQUE HANDLE
• Patient Sex: Unknown