MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; GUIDE, SURGICAL, INSTRUMENT

Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown trocar/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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.

Event Description

It was reported that during the procedure on (b)(6) 2021, when surgeon was about to put the 120 degree antegrade screw in a femoral recon nail, the trocars were extremely hard to advance in the aiming arm.Surgeons requested it to be replaced.The screw was able to be placed and the procedure was completed.Patient consequence is unknown.No surgical delay.No other medical intervention required.This report is for (1) unknown trocar.This is report 5 of 5 for complaint (b)(4).

• Brand Name: UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12253087
• MDR Text Key: 264381754
• Report Number: 2939274-2021-04347
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: RADIOLUCENT INSERTION HANDLE FRN; UNK - AIMING ARM; UNK - FRN RECON SCREW; UNK - NAILS: FEMORAL