MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown rafn spiral blade/unknown lot. Part and lot number are unknown; udi number 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. 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 patient underwent a procedure on an unknown date, with antegrade approach for a non-union at femoral shaft nonunion. Postoperatively, there was no fracture noted and no post-op complication. Patient had a ballistic femoral shaft fracture treated at an osh with a carbofix plate. This later became infected, and a large portion of femoral shaft was resected. Surgeon placed an antegrade rafn with cement spacer. Treated this with masquelet technique at 4 months after long term iv antibiotics. Partial union and surgeon plans to return to or for nail exchange and repeat grafting in near future. There was an evidence of healing reported. No further information is available. This report is for an unknown rafn spiral blade. This is report 1 of 4 for (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE
• 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: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12347666
• MDR Text Key: 267440315
• Report Number: 2939274-2021-04755
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• 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: 08/10/2021
• 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: 08/20/2021 Patient Sequence Number: 1

Treatment

UNK - END CAPS: RAFN; UNK - NAILS: RAFN; UNK - SCREWS: LOCKING