MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: HINDFOOT ARTHRODESIS NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown hindfoot arthrodesis nail/unknown lot.Part and lot number are unknown; udi number is unknown.Exact date of implant is unknown; device was reported implanted sometime in 2019.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 on (b)(6) 2021, an unknown patient underwent a revision procedure due to a non-union of an ankle fusion.The devices were originally implanted in 2019.The hardware was removed successfully.This report is for an unknown hindfoot arthrodesis nail.This is report 1 of 4 for (b)(4).

• Brand Name: UNK - NAILS: HINDFOOT ARTHRODESIS NAIL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14021895
• MDR Text Key: 288670339
• Report Number: 2939274-2022-01209
• 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: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• 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 - END CAPS: HINDFOOT ARTHRODESIS NAIL; UNK - NAIL HEAD ELEMENTS: HINDFOOT SPIRAL BLADE; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Required Intervention