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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELMIRA SYNTHES USA LLC TFNA FENESTRATED HELICAL BLADE 95MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ELMIRA SYNTHES USA LLC TFNA FENESTRATED HELICAL BLADE 95MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 04.038.395
Device Problems Device Slipped (1584); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2021
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Reporter is a j&j employee. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for trochanteric fracture with tfna helical blades in question. During the surgery, the sales rep saw a gap between the implant and the connection part of the insertion instrument on the fluoroscopic screen which would not occur if it was connected normally. He reported to the surgeon and the surgeon removed the implant. The surgeon used the other same size implant which was going to be used in other surgery. Procedure was completed successfully with thirty(30) minutes surgical delay. Concomitant device reported: unknown hammer (part# unknown; lot# unknown; quantity: 1). Unknown reamer (part# unknown; lot# unknown; quantity: 1). This report is for one (1) tfna fenestrated helical blade 95mm - sterile. This is report 1 of 2 for complaint (b)(4).
 
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Brand NameTFNA FENESTRATED HELICAL BLADE 95MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
ELMIRA SYNTHES USA LLC
35 airport road
horseheads NY 14845
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12441857
MDR Text Key271128763
Report Number8030965-2021-07571
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.038.395
Device Lot Number26P4787
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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