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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024 upon putting the tfna back up for preparation for sterilization, it was noticed that the helical blade/lag screw coupling screw was getting stripped inside the helical blade inserter.The coupling screw was screwed into another helical blade inserter and the coupling screw screwed in and out without any trouble so it's the inside of the helical blade inserter that is stripped so it needs to be replaced with a new one.There was no adverse event and patient consequences.The patient does not require a revision surgery.
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: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.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
Additional information received states that there was no allegation against the helical blade/lag screw coupling screw.No laboratory tests were taken due to the clinical findings.
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.The previous g3 (follow-up #1) was submitted in error; the correct g3 was 12/23/2024.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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
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, h6 product investigation: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the inner threads of the helical blade inserter were stripped.In addition,n the proximal end of the shaft had scratches this damage is consistent with other tools and hard edges coming in contact with the device.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces a dimensional inspection was not performed since it did not apply to the complaint condition.A functional test could not be performed, since the mating device was not returned.However, the complaint allegation can be confirmed due to the stripped condition of the device.The overall complaint was confirmed as the observed condition of the helical blade inserter would have contributed to the complained device issue.Based on the investigation findings, it seems 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 potential safety signals will be monitored through complaint trending and other post-market safety surveillance activities.Device history review (dhr): part number: 03.037.024.Lot number: t174263.Manufacturing site: tuttlingen.Release to warehouse date: 02-may-2019.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: 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20892005
• Report Number: 8030965-2024-14793
• Device Sequence Number: 20776525
• Product Code: HSB
• UDI-Device Identifier: 10886982070401
• UDI-Public: (01)10886982070401(10)T174263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,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: T174263
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 12/23/2024; 01/13/2025; 01/22/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 12/26/2024; 12/26/2024; 01/14/2025; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HELICAL BLADE/SCREW COUPLING SCREW
• Patient Sex: Unknown