MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number 04.037.259S

Device Problem Use of Device Problem (1670)

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

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

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 patient underwent a trochanteric fixation nail advanced (tfna) procedure on (b)(6) 2021.The surgeon was shown the nail before opening the sterile package.The package was opened, and the nail was inserted.After looking at the nail on fluoroscopy, the surgeon realized the nail was incorrect and backed the nail out.The correct nail was then inserted.The procedure was successfully completed with a delay of five (5) minutes.This report is for a 12mm/130 degree titanium (ti) cannulated tfna nail.This is report 1 of 1 for (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11744605
• MDR Text Key: 268271528
• Report Number: 2939274-2021-02141
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982097392
• UDI-Public: (01)10886982097392
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.259S
• Device Catalogue Number: 04.037.259S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2021
• 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