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	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 report, a follow-up report will be filed as appropriate.Additional narrative: h3, h6: a review of the receiving inspection (ri) for verse poly driver, handle was conducted identifying that lot number pu140548 released in one batch.Batch1: released july 12, 2019, 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.The product was not returned to medtech orthopedics; however, photos were received for review.The evidence provided was not sufficient to confirm the reported event unable to assemble.Functionality issues and device interaction issues cannot be evaluated through photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint condition.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 complaint condition.As part of medtech orthopedics 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.
Event or Problem Description
It was reported that patient underwent posterior spinal fusion on an unknown date in 2025.The verse polydriver handle would not retain the screwdriver shaft.Another instrument was used.Procedure was completed successfully with no 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.H11 additional narrative: h3, h6: the product was not returned to medtech orthopedics, however photos were provided for review.The evidence provided was not sufficient to confirm the reported event unable to assemble.Functionality issues and device interaction issues cannot be evaluated through photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint condition.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 complaint condition.As part of medtech orthopedics 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 :a review of the receiving inspection (ri) for verse poly driver, handle was conducted identifying that lot number pu140548 released in one batch.Batch1: lot qty of (b)(4).Units were released jul 12, 2019 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.
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.H3, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device revealed that the verse poly driver, handle was not observed with cosmetic damage and no non-conformances were found.A functional test was performed, however, the returned coupling device is not compatible with the poly driver, handle.Which prevented x15 driver final tightener from being properly inserted into the poly driver, handle.A dimensional inspection not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the verse poly driver, handle 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 a review of the receiving inspection (ri) for verse poly driver; handle was conducted identifying that lot number pu140548 released in one batch.Batch1: lot qty of (b)(4) units were released jul 12, 2019 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 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 ; 3035526892
• MDR Report Key: 21379183
• Report Number: 1526439-2025-00253
• Device Sequence Number: 8273556
• Product Code: LXH
• UDI-Device Identifier: 10705034477138
• UDI-Public: (01)10705034477138(10)PU140548
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: PU140548
• 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: 02/02/2025
• Supplement Date Received by Manufacturer: 03/14/2025; 05/12/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/18/2025; 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2019
• 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