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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Non-union Bone Fracture (2369)
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, using retrograde approach for a supracondylar fracture including those with intraarticular ext. And ballistic at supracondylar femur. Postoperatively, there was no known fracture noted. Patient experienced recalcitrant nonunion. Patient was shot with an ak-47. 5in bone defect. Treated with retrograde rafn and cement spacer. Masquelet technique at 3 months. Didn't fully heal and implant was removed without failure and replaced with non-synthes retrograde nail and repeat grafting. 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 5 for (b)(4).
 
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Brand NameUNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE
Type of DeviceROD, 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 Key12348053
MDR Text Key267462889
Report Number2939274-2021-04760
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received08/20/2021
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 Received08/10/2021
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 - BIOMATERIAL - CEMENT; UNK - END CAPS: RAFN; UNK - NAILS: RAFN; UNK - SCREWS: LOCKING
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