MAUDE Adverse Event Report: DEPUY SPINE INC TOP LOADING DEROTATION FRAME; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	286737010
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
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.H3, h4, h6 investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the retaining washer was broken apart.Broken fragment was returned for analysis.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces, as per event description during user wrong manipulation.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the top loading derotation frame would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to user, 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 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.The following drawings reflecting the current and manufactured revisions were reviewed: dwg-887019669 rev e (current) / rev c (manufactured).Dimensional inspection: n/a.Device history lot: a review of the receiving inspection (ri) for top loading derotation frame, was conducted identifying that lot number: gm4337001 released in two batches.Batch1: lot qty of (b)(4) units were released on jul 30, 2015 with no discrepancies.Batch2: lot qty of (b)(4) units are released on jun 22, 2015 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.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device was used for treatment, not diagnosis.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
During ais scolosis correction with expedium verse and expedium vbd system the assistant tightened the instrument in the wrong direction (loosening) and broke off the blocking mechanism that prevents the device from disassembling.The 3 pieces were recovered from situ with a tweezer and item was replaced with a new one.Not more than 2min were lost in the overall procedure.Of 4+ hours.

• Brand Name: TOP LOADING DEROTATION FRAME
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 21943166
• Report Number: 1526439-2025-00556
• Device Sequence Number: 18406165
• Product Code: LXH
• UDI-Device Identifier: 10705034214702
• UDI-Public: (01)10705034214702(17)420927(10)GM4337001
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 04/29/2025

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: 286737010
• Device Lot Number: GM4337001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2015
• 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