MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL Ø10 125° L170 TIMO15; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.012S

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2021, the patient underwent a surgery with tfna implants.After surgery, it was reported that a removal surgery via bha would be performed on (b)(6) 2022.The reason for removal and the date of event, etc., details are unknown at this point.No further information is available.This report is for one (1) tfna fem nail ø10 125° l170 timo15.This is report 1 of 4 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Initial 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.(b)(4).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.

• Brand Name: TFNA FEM NAIL Ø10 125° L170 TIMO15
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15013482
• MDR Text Key: 295867930
• Report Number: 8030965-2022-04835
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819649460
• UDI-Public: (01)07611819649460
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2022

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: 04.037.012S
• Device Lot Number: 302P081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR 5 L30 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA HELICAL BLADE PERF L90 TAN
• Patient Outcome(s): Required Intervention