MAUDE Adverse Event Report: Depuy Spine Inc ROD CUTTER 3.5 AND 4.0 RODS; INSTRUMENT, CUTTING, ORTHOPEDIC

Catalog Number	202000135
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
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 returned to depuy synthes for evaluation, and an investigation was conducted in accordance with depuy synthes procedures.Visual inspection of the returned device found one of the functional jaw was broken.Broken fragment remained attached by the screw.No other anomalies were noted over the surface of the broken area nor the device.The reported complaint was confirmed based on the evaluation results.The investigation traced the potential cause to a component failure that was caused by exposure to unintended forces.Properly handling and attention to the approved use of the device diminishes the risk of failure.It has been determined that no corrective or preventive actions are proposed.There is no indication that a design or manufacturing issue caused the reported condition.As part of depuy synthes quality processes, all devices are manufactured, inspected, and released in accordance with approved specifications.Additional monitoring for potential safety signals is conducted through complaint trend analysis as part of post-market safety surveillance activities.Device history review = > a review of the receiving inspection (ri) for rod cutter 3.5 and 4.0 rods was conducted identifying that lot number gs676415 released in four batch.¿ batch1: lot qty of (b)(4) units are released on aug 11, 2020 with no discrepancies ¿ batch2: lot qty of (b)(4) units were released on sep 8, 2020 with no discrepancies.¿ batch3: lot qty of (b)(4) units were released on sep 9, 2020 with no discrepancies.¿ batch4: lot qty of (b)(4) units were released on oct 14, 2020 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.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: ROD CUTTER 3.5 AND 4.0 RODS
• Common Device Name: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): Depuy Spine Inc; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50675190
• Report Number: 1526439-2026-01405
• Device Sequence Number: 13349501
• Product Code: HTZ
• UDI-Device Identifier: 10705034530536
• UDI-Public: (01)10705034530536(10)GS676415
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 202000135
• Device Lot Number: GS676415
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/29/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/13/2026
• Supplement Date Received by Manufacturer: 09/25/2026; 09/29/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 09/28/2026; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2020
• 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