MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - END CAPS: RAFN ROD, FIXATION, INTRAMEDULLARY

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

Patient Problem Muscular Rigidity (1968)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown end cap/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.

Event Description

It was reported that, the patient underwent a procedure with retrograde approach for a supracondylar fractures including those with intraarticular extension and poly trauma at supracondylar femur. Postoperatively, there was a union of fracture noted and patient experienced a knee stiffness. Patient had a segmental femur with supracondylar and shaft fractures. Also multi ligamentous knee on the same side and contralateral elbow dislocation. Judet quadri cepsplasty performed for knee rom at final follow-up. There was an evidence of healing reported. This report is for one (1) unk - end caps: rafn. This is report 3 of 4 for complaint (b)(4).

• Brand Name: UNK - END CAPS: RAFN
• 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: 12226132
• MDR Text Key: 263464473
• Report Number: 2939274-2021-04275
• 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,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 07/27/2021 Patient Sequence Number: 1

Treatment

UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE; UNK - NAILS: RAFN; UNK - SCREWS: NAIL LOCKING