MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE L95 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.295S

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

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.Additional narrative: 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.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 japan as follows: it was reported that on an unknown date, the patient underwent the open reduction internal fixation surgery for trochanteric fracture of femur with the tfna implants in question.The surgery was completed successfully without any surgical delay.After the surgery, non-union was confirmed on an unknown date.Therefore, the revision surgery to dhs plate was performed on (b)(6) 2019.The surgery was completed successfully without any surgical delay.It was reported that non-union was caused by the difficulty in sliding after surgery due to the use of nail inconsistent with the neck-shaft angle, and reported that dhs should have been used for the initial surgery.No further information is available.Concomitant device reported: unk plate (part# unknown; lot# unknown; quantity: unknown).His report is for one (1) tfna helical blade l95 tan this is report 2 of 4 for complaint (b)(4).

• Brand Name: TFNA HELICAL BLADE L95 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 14803027
• MDR Text Key: 295057368
• Report Number: 8030965-2022-04327
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652453
• UDI-Public: (01)07611819652453
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.295S
• Device Lot Number: 9929693
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK PLATE
• Patient Outcome(s): Required Intervention