MAUDE Adverse Event Report: SYNTHES GMBH 12MM/130 DEG TI CANN TFNA 200MM - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.243S

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

Patient Problems Pain (1994); Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 175 centimeters. Complainant part is not expected to be returned for manufacturer review/investigation. Part 04. 037. 243s, lot 71p5923: manufacturing location: (b)(4). Manufacturing date: october 06, 2020. Expiration date: september 01, 2030. This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. 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 (b)(6) as follows: it was reported that on (b)(6). , 2021, the patient underwent the open reduction internal fixation (orif) with the trochanteric fixation nail advanced (tfna) system for the fracture of the trochanteric femur. The fracture was intramedullary, and the proximal fragment displaced posteriorly. The surgeon tried to reduce the fracture; however, it did not go well, and the fracture was fixed with subtype n (ikuta classification). The surgery was completed without any surgical delay. Intramedullary fixation was observed a few days after the surgery. Recently, the patient complained of pain, and it was confirmed that the pseudoarthrosis occurred. The revision surgery for removal of the implants and the total hip arthroplasty was performed on (b)(6), 2022. This report is for a tfna nail. This is report 1 of 4 for (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 200MM - STERILE
• 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 ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14026446
• MDR Text Key: 293168480
• Report Number: 8030965-2022-02226
• Device Sequence Number: 1
• Product Code: HSB
• 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

• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 04.037.243S
• Device Lot Number: 71P5923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/06/2022 Patient Sequence Number: 1

Treatment

LOCKSCR Ø5 L36 F/NAILS TAN; TFNA END CAP EXTENS. 5 TAN; TFNA HELICAL BLADE L110 TAN