MAUDE Adverse Event Report: DEPUY SPINE INC UNIPLATE CAM TGHTNR TORQ HNDL; MISC ORTHO SURGICAL INSTR

Catalog Number	289707000
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the product was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that the uniplate cam tghtnr torq hndl exhibits signs of normal use.No cosmetic defects were observed on the surface.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was performed using torque meter.Torque handle is required to deliver 0.63 nm to 0.98 nm at intermediate setting.Actual measured values range from 1.052 nm to 1.085 nm.The complaint condition was able to be replicated as it resulted in over torquing.The overall complaint was confirmed as the observed condition of the uniplate cam tghtnr torq hndl would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the 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 reported 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.Dimensional inspection: n/a.Device history: a review of the receiving inspection (ri) for uniplate cam tghtnr torq hndl was conducted identifying that lot number km873406 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 13 dec 2018 with no discrepancies.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.
Event or Problem Description
It was reported the handle did not meet specifications for torque testing.No patient involvement.

• Brand Name: UNIPLATE CAM TGHTNR TORQ HNDL
• Common Device Name: MISC ORTHO SURGICAL INSTR
• 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: 24389026
• Report Number: 1526439-2026-00185
• Device Sequence Number: 16107573
• Product Code: LXH
• UDI-Device Identifier: 10705034224787
• UDI-Public: (01)10705034224787(10)KM873406
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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: 289707000
• Device Lot Number: KM873406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2018
• 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