MAUDE Adverse Event Report: SYNTHES GMBH 2.8 THRD GUIDE WIRE- TROCAR POINT 300; APPLIANCE, FIXATION, NAIL/BLADE/PLATE

Model Number 292.68

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

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, during intra-op while repositioning a screw intraoperatively, a 2.8 wire became lodged inside a 6.5 cannulated screw.The surgical tech said the wire had been bent intra-op so there was no allegation against the products.The wire was removed and a new wire was selected and screw was implanted.No adverse events occurred.There was no reported surgical delay.Procedure was completed successfully.There was no fragments completed.It was unknown if were they removed easily without additional intervention.There was no patient consequences.This complaint involves two (2) devices.This report is for one (1) 2.8 third guide wire- trocar point 300 this is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Product complaint #(b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.Complainant part is not expected to be returned for manufacturer review/investigation.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 follow-up medwatch will be filed as appropriate.

• Brand Name: 2.8 THRD GUIDE WIRE- TROCAR POINT 300
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE
• 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: 16549818
• MDR Text Key: 311669033
• Report Number: 8030965-2023-03195
• Device Sequence Number: 1
• Product Code: LXT
• UDI-Device Identifier: 10886982180803
• UDI-Public: (01)10886982180803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 292.68
• Device Catalogue Number: 292.68
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 6.5MM CANNULATED SCREW 16MM THREAD 90MM
• Patient Sex: Female