MAUDE Adverse Event Report: DEPUY SPINE INC VERSE POLY DRIVER, HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	299704152
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
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.
Event or Problem Description
It was reported that during a exapedium verse surgery the scrub nurse noted that verse screwdriver shaft and verse polydriver handle disengages from each other during tightening of the handle to the screwhead.The screw would not stay connected to the shaft and it could not be inserted correctly.The cause of the disengagement seems to be a malfunction of the closure mechanism of the polydriver handle.A second instrument was used to complete the surgery.There was no surgical delay and no patient consequence.No other medical intervention was required.The procedure was successfully completed.
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: added: d9, h4.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.H11 additional narrative: h3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned sample revealed that the verse poly driver, handle exhibits signs of normal use, this condition is normal for this type of reusable devices.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional evaluation was performed several attempts of assemble and disassembly were made with the mating device (299704155) also returned in this complaint.No issues or problems were detected.Therefore, the complaint allegation cannot be confirmed.The overall complaint was not confirmed as the observed condition of the verse poly driver, handle 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 verse poly driver, handle, was conducted identifying that lot number lc42084 released in one batch.¿ batch1: lot qty of (b)(4).Units were released on feb 20, 2016 with no discrepancies ¿ batch2: lot qty of (b)(4).Units are released on feb 19, 2016 with no discrepancies supplier: (b)(4).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: VERSE POLY DRIVER, 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 ; 8472871282
• MDR Report Key: 21148802
• Report Number: 1526439-2025-00064
• Device Sequence Number: 9329956
• Product Code: LXH
• UDI-Device Identifier: 10705034477138
• UDI-Public: (01)10705034477138(10)PU104341
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: 299704152
• Device Lot Number: PU104341
• 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: 12/31/2024
• Supplement Date Received by Manufacturer: 03/03/2025; 03/19/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/12/2025; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2016
• 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
• Patient Sex: Unknown