MAUDE Adverse Event Report: SYNTHES GMBH TFNA END CAP EXTENS. 0 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.000S

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 end cap extens.0 tan.This is report 4 of 4 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.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 END CAP EXTENS. 0 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15013613
• MDR Text Key: 295869944
• Report Number: 8030965-2022-04839
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819648708
• UDI-Public: (01)07611819648708
• 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: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.000S
• Device Lot Number: 261P508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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 FEM NAIL Ø10 125° L170 TIMO15; TFNA HELICAL BLADE PERF L90 TAN
• Patient Outcome(s): Required Intervention