MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: RFNA; ROD, FIXATION, INTRAMEDULLARY

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Non-union Bone Fracture (2369); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported that on an unknown date, two locking screws backed out after the initial surgery.The implant was removed on (b)(6) 2021.It was replaced with a stryker nail.No further information provided.This report is for one (1) unk - nails: rfna.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

This report is for an unknown nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.

Manufacturer Narrative

The initial complaint was reviewed and found not reportable.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.

• Brand Name: UNK - NAILS: RFNA
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13385286
• MDR Text Key: 284629450
• Report Number: 2939274-2022-00266
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• 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: 02/25/2022
• 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 - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention