MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEM: TFNA LAG SCREW; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - nail head elem: tfna lag screw/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.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.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 an unknown date, patient underwent a surgical procedure.It's a trochanteric fixation nail advanced (tfna) nail inserted incorrectly, and it was removed.A successful removal was completed but they do want to report the lag screw in a face with a nail as not function or not locked.It is unknown if there was surgical delay.Patient outcome was unknown.Concomitant device reported: unk - nail head elements: tfna helical blade (part # unknown; lot # unknown; quantity: 1), unk - screws: nail distal locking (part # unknown; lot # unknown; quantity: 1).This complaint involves two(2) devices.This report is for (1) unk - nail head elem: tfna lag screw.This report is 1 of 1 for (b)(4).

• Brand Name: UNK - NAIL HEAD ELEM: TFNA LAG SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13027983
• MDR Text Key: 282507021
• Report Number: 2939274-2021-07149
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• 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: 11/19/2021
• 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: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - NAILS: TFNA; UNK - SCREWS: NAIL DISTAL LOCKING