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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: FNS BOLT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAIL HEAD ELEMENTS: FNS BOLT; 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 Date 01/01/2021
Event Type  Injury  
Event Description
It was reported that on unknown date, patient had a femoral neck fracture that was fixed on (b)(6) 2021 using the depuy synthes femoral neck system.The fracture went onto a nonunion.The patient returned to surgery for removal of the femoral neck implants and implantation of a total hip arthroplasty.All the femoral neck hardware was removed with ease.The 5.0 mm locking screw was broken at the screw plate junction.The broken piece was removed using a trephine.All hardware was removed successfully.Patient status is unknown.This complaint involves four (4) devices.This report is for (1)unk - nail head elements: fns bolt.This report is 2 of 4 for (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).This report is for an unk - nail head elements: fns bolt/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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
Product complaint # (b)(4).This report is for an unk - nail head elements: fns bolt/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 unknown date, patient had a femoral neck fracture that was fixed on (b)(6) 2021 using the depuy synthes femoral neck system.The fracture went onto a nonunion.The patient returned to surgery for removal of the femoral neck implants and implantation of a total hip arthroplasty.All the femoral neck hardware was removed with ease.The 5.0 mm locking screw was broken at the screw plate junction.The broken piece was removed using a trephine.All hardware was removed successfully.Patient status is unknown.This complaint involves four (4) devices.This report is for (1)unk - nail head elements: fns bolt.This report is 2 of 4 for (b)(4).
 
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Brand Name
UNK - NAIL HEAD ELEMENTS: FNS BOLT
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 Key13048742
MDR Text Key286123746
Report Number2939274-2021-07166
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
Reporter Occupation Physician
Type of Report Initial
Report Date 12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
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 Received11/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
FEMORAL NECK SYSTEM PL 1 HOLE - STERILE; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - SCREWS: FNS LOCKING
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient SexMale
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