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

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).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 95MM
• Type of Device: ROD, 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 Key: 12441857
• MDR Text Key: 271128763
• Report Number: 8030965-2021-07571
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• 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 Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.038.395
• Device Lot Number: 26P4787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown