MAUDE Adverse Event Report: SYNTHES GMBH 2.8MM GUIDE WIRE WITH FLUTES 450MM; PIN,FIXATION,SMOOTH

Catalog Number 02.207.001

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Unspecified Tissue Injury (4559)

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.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: an order of ancillary was performed but the surgeon did not received all the devices that was expected.The 2.8mm guide wire was missing, causing the interruption of the surgical procedure.The surgeon requested instrumentation for the ablation of the screw scfe via the ascaly system.The fzt504ns instrumentation was shipped because there is no ablation system in the loan park.As the request was regarding an ablation, the kit with the sterile implants has not been sent (fqt504st) but the 2.8mm guide wire is available sterile in the fqt504st kit.An investigation has been opened to identify the cause of this issue.The patient had been anesthetized and was incised before the surgeon noticed the device was missing, so the procedure was canceled.The procedure will be planned again.This report is for one (1) 2.8mm guide wire with flutes 450mm.This is report 1 of 1 for (b)(4).

• Brand Name: 2.8MM GUIDE WIRE WITH FLUTES 450MM
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 11407547
• MDR Text Key: 240025682
• Report Number: 8030965-2021-01583
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07611819478756
• UDI-Public: (01)07611819478756
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.207.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1