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 Non-union Bone Fracture (2369)

Event Type  Injury  

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.The surgeon 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) this report is for one (1) tfna end cap extens.0 tan this is report 3 of 4 for complaint.

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.(b)(6) medical center.(b)(6) japan, (b)(6) japan.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.

• 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
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 14806718
• MDR Text Key: 295033368
• Report Number: 8030965-2022-04328
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.000S
• Device Lot Number: 9212090
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK PLATE
• Patient Outcome(s): Required Intervention