MAUDE Adverse Event Report: SYNTHES GMBH HELICAL BLADE INSERTER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.037.024
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an (b)(6) 2025, the coupling screw for the tfna was stuck in the helical blade inserter and the scrub tech was not able to get the helical blade/screw coupling screw to thread into the helical blade inserter.The surgery was completed successfully.The helical blade was inserted over the guide wire without the use of the coupling screw.No delay in surgical time or negative consequences resulted.
Additional Manufacturer Narrative
Product complaint # (b)(4).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: if information is obtained that was not available for the initial medwatch, a follow-up medwatch 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: added: d9.Corrected: g1.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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: h3, h6: photo investigation.The product was not returned to medtech orthopaedics; however.Photos were provided for review.The photo investigation revealed that ' 03.037.024, helical blade inserter¿ had stripped.However, the reported condition of jammed/seized and inability to assemble/disassemble for device remains unconfirmed.The device exhibits damage consistent with repeated use.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.The provided evidence was not sufficient to confirm the reported event of jammed/seized and inability 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 helical blade inserter would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed to end of life 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 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.H3, h6: physical device investigation.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found slightly scratches in the middle shaft.However, this condition is normal in this type of reusable devices.No signs of manufactured defects or anything that could help to the malfunction of the device.Additionally, the yellow/red color markings that help in aligning the helical blade inserter to the mating devices were observed to be discolored.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional evaluation was performed several attempts of assemble and disassembly were made.It was possible to preformed the complete assembly process, the mating devices used was returned also in this complaint (03.037.026, helical blade/screw coupling screw) and no malfunction in the assemble process were found.The assembly work as expected.The overall complaint was not confirmed as the observed condition of the helical blade inserter 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.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.Device history review: part number: 03.037.024.Lot number: t145425.Manufacturing site: tuttlingen.Release to warehouse date: 14-mar-2017.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 report, a follow-up report will be filed as appropriate.

• Brand Name: HELICAL BLADE INSERTER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen CO ; GM
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 21963463
• Report Number: 8030965-2025-04558
• Device Sequence Number: 21122817
• Product Code: HSB
• UDI-Device Identifier: 10886982070401
• UDI-Public: (01)10886982070401(10)T145425
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 03.037.024
• Device Lot Number: T145425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/12/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 06/03/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/08/2025; 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2017
• 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 Age: 83 YR
• Patient Sex: Male
• Patient Weight: 75 KG