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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RFNA / 12 / 380 5 DEG BEND / STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC RFNA / 12 / 380 5 DEG BEND / STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.233.238S
Device Problem Migration (4003)
Patient Problem Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative
Additional narrative: without a lot number the device history records review could not be completed. Product was not returned. 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 that on (b)(6) 2021, a revision surgery was performed to tighten/reinsert distal screws that backed out of the rfna implant postoperatively. Non union distal femur fracture also occured. The distal screws of the rfna nail backed out post operatively during the healing process and prior to any weight bearing. Another procedure was needed to reinsert the distal screws of the rfna. No further information provided. This report is for one (1) rfna / 12 / 380 5 deg bend / sterile. This is report 1 of 2 for (b)(4).
 
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Brand NameRFNA / 12 / 380 5 DEG BEND / STERILE
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 (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12394246
MDR Text Key269028683
Report Number2939274-2021-05078
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201346
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.233.238S
Device Catalogue Number04.233.238S
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 Received09/08/2021
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: 08/31/2021 Patient Sequence Number: 1
Treatment
UNK - END CAPS: FEMORAL NAIL; UNK - SCREWS: NAIL LOCKING
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