MAUDE Adverse Event Report: SYNTHES GMBH EXPERT A2FN NAIL Ø13 R CANN L420 TAN LIG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.009.664S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

This report is 1 of 7 for (b)(4).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

A2fn removed from patient after complaints of pain.Implant removed successfully.

• Brand Name: EXPERT A2FN NAIL Ø13 R CANN L420 TAN LIG
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14166856
• MDR Text Key: 289741921
• Report Number: 8030965-2022-02590
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.009.664S
• Device Lot Number: 3703017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: END-CAP F/A2FN CANN EXTENS. 10 TAN GREY; EXPERT A2FN NAIL Ø13 R CANN L420 TAN LIG; LOCKSCR Ø5 L48 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L50 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L58 F/NAILS TAN LIGHT GREEN; LOCKSCR Ø5 L76 F/NAILS TAN LIGHT GREEN
• Patient Outcome(s): Required Intervention