MAUDE Adverse Event Report: SYNTHES GMBH 12MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.244S

Device Problem Fracture (1260)

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

Event Type  Death  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported a patient who had a trochanteric fixation nail advanced (tfna) had a fractured. A revision surgery occurred. Original implant date was (b)(6) 2021. Explant date was (b)(6) 2022. Patient deceased post revision surgery. This is report 1 of 1 for (b)(4). This report is for a tfna nail.

Manufacturer Narrative

Additional narrative: unknown when fracture occurred. 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 history: part #: 04. 037. 244s; lot #: 57p0049. Manufacturing site: (b)(6). Supplier: (b)(6). Release to warehouse date: (b)(6) 2020. Expiration date: 01 may 2030. No code available is for injury, revision surgery and death. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. 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: 12MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14218869
• MDR Text Key: 290163564
• Report Number: 8030965-2022-02733
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 04.037.244S
• Device Lot Number: 57P0049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/27/2022 Patient Sequence Number: 1

Treatment

UNK - NAIL HEAD ELEM: TFNA LAG SCREW.; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE.; UNK - SCREWS: NAIL DISTAL LOCKING.