MAUDE Adverse Event Report: SYNTHES GMBH UNK - CABLE/WIRE; WIRE, SURGICAL

Catalog Number 03.043.005

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2023

Event Type  malfunction  

Event Description

It was reported that on november 19, 2023 an orthopedic surgeon was performing a suprapatellar tibial nail.During the procedure the doctor inserted a guide wire of 8-11mm diameter nail.The surgeon introduced the guided wire sleeve behind the patella to get a certain point for the nail and positioned revise in x-ray with the 2.2 mm guide wire through cannulated wire sleeve upon introducing guided wire top of the tibia.The guide wire became bent into the guide wire sleeve.Upon seeing this, the guide wire sleeve was removed, the surgeon attempted to remove the guide wire but was unsuccessful.So, the surgeon continued to use the guides sleeve as specific guide wire for rest of the case.The procedure was completed successfully.This report involves one (1) wire guide / multihole / long for nails ø 8-11mm.This is report 2 of 2 for (b)(4).

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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.D10 therapy date: november 19, 2023.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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 follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - CABLE/WIRE
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18310170
• MDR Text Key: 330278007
• Report Number: 8030965-2023-15578
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 10886982297150
• UDI-Public: 10886982297150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 0
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.043.005
• Device Lot Number: 295P487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - NAILS: TIBIAL; WIRE GUIDE / MULTIHOLE / LG NL 8-11