MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5; DRIVER, PROSTHESIS

Catalog Number	279702000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
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 report, a follow-up report will be filed as appropriate.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H3, h6 investigation summary: the product was not returned to medtech orthopaedics, however photos were provided for review.The photo investigation revealed that for the single innie inserter, the provided evidence was not sufficient to confirm the reported event of unable to assemble.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the single innie inserter would not contribute 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 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.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.
Event or Problem Description
It was reported that during the procedure, when passing the internal screws and using the screwdrivers, it was evident that one of the screwdrivers did not grip the nut well and when detailing it a little more it was observed together with the specialist that the tip of this screwdriver was in very poor condition, it was then solved with another screwdriver of the same reference and characteristics that also comes inside the equipment.In addition to this, when performing the counter torque with the screwdrivers it was presented that neither of the two the tips fit well in the nut, so they rolled and did not apply the proper torque (they did not grip the nut well).With these screwdrivers there was no way to find a solution in this regard because there were no more units of the same reference and the doctor had to adjust the screws with another reference which previously, it was mentioned that it was in good condition and was the only functional screwdriver that was available, thus managing to complete the surgery successfully, without affecting the patient and without alterations in surgical time.

• Brand Name: EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5
• Common Device Name: DRIVER, PROSTHESIS
• 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: 22104379
• Report Number: 1526439-2025-00697
• Device Sequence Number: 8233007
• Product Code: HWR
• UDI-Device Identifier: 10705034198408
• UDI-Public: (01)10705034198408
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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

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: 279702000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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