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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - END CAPS: RAFN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Malunion of Bone (4529); Unspecified Musculoskeletal problem (4535)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: 510k: this report is for an unknown rafn end cap/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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 on (b)(6) 2021 the patient presented with a fracture of the left distal femur and was operated on (b)(6) 2021 for fixation using the retrograde/antegrade femoral nail (rafn) system. On (b)(6) 2021, during routine follow up the x-ray had demonstrated loosening of the distal transverse screw consistent with patient complaining of local sensitivity. The surgeon removed the loose screw under local anesthesia. The surgeon continued normal follow-up course for the patient. On (b)(6) 2022, at routine follow-up, the x-ray showed signs of varus collapse. The surgeon stated the patient¿s bone is healed and that the patient is ambulatory. As of (b)(6) 2022, the surgeon does not plan to revise this patient. This complaint captures the reported post-op event of signs of varus collapse, while related complaint (b)(4) captures the reported postop event of loosening of the distal transverse screw. This report is for unk - end caps: rafn. This is report 4 of 4 for complaint (b)(4).
 
Manufacturer Narrative
Additional narrative: 510k: this report is for an unknown rafn end cap/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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 on (b)(6) 2021 the patient presented with a fracture of the left distal femur and was operated on (b)(6) 2021 for fixation using the retrograde/antegrade femoral nail (rafn) system. On (b)(6) 2021, during routine follow up the x-ray had demonstrated loosening of the distal transverse screw consistent with patient complaining of local sensitivity. The surgeon removed the loose screw under local anesthesia. The surgeon continued normal follow-up course for the patient. On (b)(6) 2022, at routine follow-up, the x-ray showed signs of varus collapse. The surgeon stated the patient¿s bone is healed and that the patient is ambulatory. As of (b)(6) 2022, the surgeon does not plan to revise this patient. This complaint captures the reported post-op event of signs of varus collapse, while related complaint (b)(4) captures the reported postop event of loosening of the distal transverse screw. This report is for unk - end caps: rafn. This is report 4 of 4 for complaint (b)(4).
 
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Brand NameUNK - END CAPS: RAFN
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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key13563629
MDR Text Key286070690
Report Number2939274-2022-00572
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2022
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
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/18/2022 Patient Sequence Number: 1
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