MAUDE Adverse Event Report: SYNTHES GMBH PLATE-BENDING PRESS; INSTRUMENT, BENDING OR CONTOURING

Catalog Number	329.30
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the u arm was bent at the end of the bolt plate and was not locking.The issue was observed during assembly.There was no patient involvement.There was no delay.
Additional Manufacturer Narrative
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.
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: photo investigation the product was not returned to medtech orthopaedics , however photos were provided for review.The photo investigation revealed that plate-bending press has been bent.The observed condition of the device was consist with a random component failure that may have been caused by exposure to unintended force.The provided evidence was not sufficient to confirm the reported event of unable to assemble/disassemble.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the [plate-bending press] would contribute to the complained device issue.Based on the investigation findings, the plate-bending press has bent , because of cause trace 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 medtech orthopedics 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 review part number: 329.300-us lot number: 5543p96 manufacturing site: hägendorf release to warehouse date: 20-jun-2023 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the malfunction were identified.The capa jbl-capa-000388 was opened to investigate citric passivation being used instead of nitric passivation.This capa is affecting passivation only and is not related to the retention pin screwdriver short breaking during removal, but to the usage of citric passivation being used instead of nitric passivation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PLATE-BENDING PRESS
• Common Device Name: INSTRUMENT, BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 21952766
• Report Number: 8030965-2025-04480
• Device Sequence Number: 13025644
• Product Code: HXP
• UDI-Device Identifier: 10886982191953
• UDI-Public: (01)10886982191953(10)5543P96
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• 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: 329.30
• Device Lot Number: 5543P96
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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