MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM SINGLE INNIE INSERTER; DRIVER, PROSTHESIS

Catalog Number	286210110
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the following issues were observed following the use of the ancillary set: difficulty using the reducers because the screwdrivers did not fit in the reduction screwdrivers.The screwdrivers did not penetrate fully into the reducer screwdrivers, so it was not possible to insert the plug onto the implant.In addition, the rod stabilizer did not allow it to perform its function.The end was covered with a rubber cap with a hole for the screwdriver; this cap could not be removed and did not allow the stabilizer to be positioned on the rod.
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 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 outcome was reported to be fine and the procedure was completed successfully.There was no additional 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.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.H11 additional narrative: h3, h6: photo investigation: the product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed that the single innie inserter had no signs of issue.Functionality of the device cannot be assessed through photo investigation, hence complaint condition cannot be confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the single innie inserter, si 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 of single innie inserter was conducted identifying that lot number nw130810 released in four batches.Supplier : (b)(4).Batch1: lot qty of (b)(4) units were released on 02 feb 2013 with no discrepancies.Batch2: lot qty (b)(4) units were released on 11 jan 2013 with no discrepancies.Batch3: lot qty of (b)(4) units were released on 11 jan 2013 with no discrepancies.Batch4: lot qty of (b)(4) units were released on 13 sep 2016 with no discrepancies.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: EXPEDIUM SPINE SYSTEM SINGLE INNIE INSERTER
• Common Device Name: DRIVER, PROSTHESIS
• 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: 21101036
• Report Number: 1526439-2025-00023
• Device Sequence Number: 13047952
• Product Code: HWR
• UDI-Device Identifier: 10705034211091
• UDI-Public: (01)10705034211091(10)NW130810
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: 286210110
• Device Lot Number: NW130810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 01/07/2025; 02/21/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/10/2025; 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2013
• 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