MAUDE Adverse Event Report: SYNTHES GMBH VERTEBR-BODY RETAINER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.820.111
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.
Event or Problem Description
It was reported that the vertebral body retainers are not staying locked in place.
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: added: d9.Corrected: g1.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device observed corrosion over the connection joints and near the etching.A slight force is noted on the joint from the arms, most likely due to corrosion condition, however, due to inaccessibility of the inner components, the complete potential cause remains not established.A functional test was performed to both right and left ratchet mechanisms and they were able to lock properly.An issue with the locking mechanism can not be confirmed.Potential cause for the detected corrosion can be traced to maintenance, refer to the device/country specific ifu for information related to cleaning, sterilization, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the vertebr-body retainer would have not contributed 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 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.Device history lot: part number: 03.820.111.Lot number: 322p178 (wo# (b)(4)).Manufacturing site: tuttlingen.Release to warehouse date: 11-aug-2021.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VERTEBR-BODY RETAINER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24258993
• Report Number: 8030965-2026-01190
• Device Sequence Number: 18116279
• Product Code: LXH
• UDI-Device Identifier: 10705034731520
• UDI-Public: (01)10705034731520(10)322P178
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 03.820.111
• Device Lot Number: 322P178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• 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