MAUDE Adverse Event Report: SYNTHES GMBH MESH CUTTING SCISSORS LONG NOSE; MISC ORTHO SURGICAL INSTR

Catalog Number	03.503.037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
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.D1, d2a, d2b, d3, d4, g4 - 510k: this report is for unk: cutting instruments: trauma: rfna: unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a followup medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on an unknown date, when setting up for the procedure prior to patient interaction, it was brought to attention that the mesh cutters were broken.No other information was provided.This report is for one (1) unk: cutting instruments: trauma.This is report 1 of 1 for complaint : (b)(4).
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, h4, h6: part number: 03.503.037, lot number: t103945, manufacturing site: tuttlingen, release to warehouse date: 13-mar-2014.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

• Brand Name: MESH CUTTING SCISSORS LONG NOSE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18720459
• Report Number: 8030965-2024-02574
• Device Sequence Number: 15025771
• Product Code: LXH
• UDI-Device Identifier: 10887587011639
• UDI-Public: 10887587011639
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• 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
• Report Date (Section B): 02/16/2024

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: 03.503.037
• Device Lot Number: T103945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2014
• 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