MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM; TAP, BONE

Catalog Number	279702400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nerve Damage (1979); Insufficient Information (4580)
Date of Event	05/14/2026
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: h3, h6: 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.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that 4.35mm double-lead tap had broken.The observed condition of the device was consist with a random component failure that may have been caused by exposure to unintended force.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the 4.35mm double-lead tap would contribute to the complained device issue.Based on the investigation findings, potential cause attributed to component failure 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 depuy synthes 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 a 4.35mm double-lead tap broke intraoperatively during a pediatric scoliosis surgery.The tip of the tap broke off while preparing the left t4 pedicle, but the fragment was easily recovered.Following the incident, the patient experienced loss of motor function on the right side, with sensory signals recovering but not the motor function.The surgery was delayed by 60-90 minutes to remove and reinsert screws from t4-6 bilaterally, and a neurosurgeon was called to repair a cerebrospinal fluid (csf) leak.The patient underwent an awake test, rods and set screws were implanted, and the surgery was completed without deformity correction.Multiple motor tests showed no change, and the patient was sent for mri post-surgery.

• Brand Name: EXPEDIUM
• Common Device Name: TAP, BONE
• 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: 25434899
• Report Number: 1526439-2026-00675
• Device Sequence Number: 10136728
• Product Code: HWX
• UDI-Device Identifier: 10705034198590
• UDI-Public: (01)10705034198590(10)NG61016
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 279702400
• Device Lot Number: NG61016
• 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: 05/13/2026
• Supplement Date Received by Manufacturer: 06/12/2026; 06/26/2026; 06/29/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 06/18/2026; 06/29/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown