MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 95MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.038.195S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # pc-(b)(4).Additional narrative: patent identifier: mrn:(b)(6).Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.

Event Description

It was reported that on (b)(6), 2021, the patient is scheduled for tfna revise due to fracture displacement.During extraction the nail was very difficult to connect the extractor.The set screw was back out enough to remove the lag screw and the smith and nephew conical extractor was connected and the nail was successfully removed.It is unknown if the procedure was successfully completed.There was a patient consequence reported.This complaint involves three (3) devices.This report is for (1) tfna fenestrated screw 95mm - sterile this report is 3 of 3 for pc-(b)(4).Related product complaint: pc-(b)(4).

• Brand Name: TFNA FENESTRATED SCREW 95MM - 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): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13113600
• MDR Text Key: 288800294
• Report Number: 2939274-2021-07270
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982098757
• UDI-Public: (01)10886982098757
• 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: 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: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.195S
• Device Catalogue Number: 04.038.195S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• 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
• Treatment: 10/130 DEG TI CANN TFNA 170 - STERILE; NAIL EXTRACTOR
• Patient Age: 47 YR
• Patient Sex: Female