MAUDE Adverse Event Report: DEPUY SPINE INC VERSE SLEEVE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	301019041
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the crossnav screwdriver tends to un-tighten itself from the screw at some point during the screw insertion.No impact on patient, no impact on the surgery.The surgeon is concerned with the screws properly attached/secured onto the screwdriver as described in the surgical technique.No surgical delay.Procedure completed successfully.
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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: d4 (lot).D9.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Photo investigation: the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that '301019041, verse sleeve¿ had inability to assemble.Based on the available evidence, a definitive root cause could not be determined.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the verse sleeve would contribute to the complained device issue.Based on the investigation findings, potential cause cannot be established and 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 complaint condition.As part of 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 the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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: added: d9 and h4 corrected: d4 (primary udi number).H3, h6: the product was returned to j&j medtech orthopaedics for evaluation.A visual inspection of the returned verse sleeve revealed no signs of nonconformance.The video evidence shows that the verse sleeve is functioning properly.It appears that the verse sleeve is being assembled with a handle and screw; therefore, we cannot confirm any assembly issues, as it is properly attached to the mating components (handle and screw).The interaction between the verse sleeve and the exped verse nav driver is working smoothly, and the locking mechanism works without problems.A functional test could not be performed because the associated handle and screw was not returned for examination.The distal tip and the proximal end have no defects.A dimensional inspection was performed and met specifications.The overall complaint was not confirmed as the observed condition of the verse sleeve 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 lot a review of the receiving inspection (ri) for verse sleeve, was conducted identifying that lot number pu226530 was released in two batches.Batch1: lot qty of (b)(4) units were released on nov 8, 2024 with no discrepancies.Batch2: lot qty of (b)(4) units were released on sep 20, 2024 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: VERSE SLEEVE
• Common Device Name: ORTHOPEDIC STEREOTAXIC 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: 21775165
• Report Number: 1526439-2025-00467
• Device Sequence Number: 9658431
• Product Code: OLO
• UDI-Device Identifier: 10705034561677
• UDI-Public: (01)10705034561677(10)PU226530
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K200791
• 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: 301019041
• Device Lot Number: PU226530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 04/21/2025; 05/26/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/23/2025; 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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