MAUDE Adverse Event Report: SYNTHES GMBH USS ROD CUT+BEND-DEVICE; CUTTER, SURGICAL

Catalog Number	388.750
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
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.Additional narrative: investigation summary the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that uss rod cut+bend-device is composed by several components and only were received the operating handle, handle brown and block, these components shows wear on the surface.Bending/shearing-punch, cutting-plate, fork, shank, hinge bolt, hinge screw, bench, bent rol, plate, passscrew/screws, cylinder and cap nut were not received for evaluation.The operating handle and handle brown, they are not etched with product information or diameters as this is not required, only the block require engraved according to drawing specification and as per visual inspection the number information was correct.In addition, the distal tip was broken, wear on the surface and some number were observed blurred and the etch can be difficult to read during the inspection performed.The observed broken condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Properly handling and attention to the approved use of the device diminishes the risk of failure missing components: this condition may occur during the cleaning/sterilization process, particularly when the components are assembled or disassembled.As these procedures are often repeated, there is an increased risk of components going missing.However, without concrete evidence or further information, it is not possible to determine a root cause illegible etch: the observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed due to post manufacturing damage.A functional evaluation was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of uss rod cut+bend-device would have contributed to the complained issue.It was determined that the reusable instrument was worn from repeated use and servicing.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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 due to the age of more than 10 years of the complained device a wear or use related root cause is the most likely reason of the complained malfunction.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 on (b)(6) 2025, upon inspection after returning the rod cutter from the short-term loaner, the distribution center found that the rod diameter markings were not found on each hole.This event has no surgery involvement.

• Brand Name: USS ROD CUT+BEND-DEVICE
• Common Device Name: CUTTER, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24363205
• Report Number: 8030965-2026-01536
• Device Sequence Number: 10200675
• Product Code: FZT
• UDI-Device Identifier: 10705034773766
• UDI-Public: (01)10705034773766(10)6008
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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

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: 388.750
• Device Lot Number: 6008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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