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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 95MM STERILE; ROD, FIXATION, INTRAMEDULLARY
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 95MM STERILE; ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 04.038.295S
Device Problem Migration (4003)
Patient Problem Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2019 the patient underwent an open reduction and internal fixation (orif) of the right femur to replace trochanteric femoral nail advance (tfna) blade.The tfna helical blade was protruding past the lateral femoral cortex and protruding minimally into the femoral head causing patient discomfort.Originally, the patient was treated with a 90 mm helical blade for a hip fracture on (b)(6) 2018.The fracture had healed; the helical blade was protruding laterally about 20mm and penetrating the femoral head less than 5mm due to fracture compression.The blade was replaced with a 75 mm helical blade without incident.Concomitant devices reported: tfna nail (part/lot unknown, quantity 1); screws (part/lot unknown, quantity unknown).This report is for a tfna helical blade.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history lot : part number: 04.038.295s, lot number: h549086, part manufacturing date: 16 february 2018, manufacturing site: elmira, part expiration date: 31 january 2028, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h549086 of tfna helical blades was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot h329010 met all specifications with no issues documented that would contribute to this complaint condition.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
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
The revision procedure occurred on (b)(6) 2019.Procedure outcome and patient status are unknown.
 
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Brand Name
TFNA HELICAL BLADE 95MM STERILE
Type of Device
ROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8400231
MDR Text Key138123465
Report Number2939274-2019-56861
Device Sequence Number1
Product Code HSB
UDI-Device Identifier10886982099013
UDI-Public(01)10886982099013
Combination Product (y/n)N
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number04.038.295S
Device Catalogue Number04.038.295S
Device Lot NumberH549086
Was Device Available for Evaluation? No
Date Manufacturer Received04/09/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age88 YR
Patient Weight41
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