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

Model Number 04.038.095S

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported that on unknown date, patient underwent a procedure.It was noted that the tfna short nail broke at proximal end of the nail.The nail fractured at the cephalomedullary tfna screw opening.It is unknown if the procedure completed.Patient status is unknown.This complaint involves two (2) devices.This report is for (1) tfna screw 95mm - sterile.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: event year is reported as 2021; however exact date of event 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: event year is reported as 2021; however exact date of event 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 unknown date, patient underwent a procedure.It was noted that the tfna short nail broke at proximal end of the nail.The nail fractured at the cephalomedullary tfna screw opening.It is unknown if the procedure completed.Patient status is unknown.This complaint involves two (2) devices.This report is for (1) tfna screw 95mm - sterile.This report is 2 of 2 for (b)(4).

• Brand Name: TFNA 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: 13120187
• MDR Text Key: 286131075
• Report Number: 2939274-2021-07305
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982098498
• UDI-Public: (01)10886982098498
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• 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: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.095S
• Device Catalogue Number: 04.038.095S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• 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: TFNA FEM NAIL Ø10 130° L170 TIMO15
• Patient Outcome(s): Required Intervention
• Patient Sex: Male