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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI SPIRAL BLADE 70MM FOR TI RETROGRADE FEMORAL NAILS-EX ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI SPIRAL BLADE 70MM FOR TI RETROGRADE FEMORAL NAILS-EX ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 04.013.046
Device Problem Migration (4003)
Patient Problem Necrosis (1971)
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that a revision operation was performed. Six (6) weeks post-op there was a hindfoot spiral blade dismantle, the spiral blade backed out despite the end cap implantation to lock it in place. The ttc construct failed (hindfoot nail with spiral blade) and revision surgery was performed to remove the blade. Skin necrosis appeared caused by the spiral blade head protruding towards the back of the foot. Since the talus screw and proximal calcaneum 6. 0mm screws remained solid, no further steps were needed. Two (2) weeks post-op the patient was allowed by the surgeon to put full weight bearing. Six (6) weeks post-op [(b)(6) 2021)], a clinical follow up was made. The x-rays showed that the spiral blade had backed out. The revision surgery was performed to remove the blade. The nail and all screws remained in place. The surgeon believes it will heal without the blade. Concomitant devices: unknown hindfoot nail (part# unknown; lot# unknown; quantity: 1), unknown screws (part# unknown; lot# unknown; quantity: unknown). This report is for one (1) ti spiral blade 70mm for ti retrograde femoral nails-ex. This is report 1 of 1 for (b)(4).
 
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Brand NameTI SPIRAL BLADE 70MM FOR TI RETROGRADE FEMORAL NAILS-EX
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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11653046
MDR Text Key245356574
Report Number2939274-2021-01823
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K033618
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.013.046
Device Catalogue Number04.013.046
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 Received04/15/2021
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: 04/12/2021 Patient Sequence Number: 1
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