MAUDE Adverse Event Report: SYNTHES GMBH TI END CAP FOR TFNA 5MM EXTN - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.005S

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

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

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Patient height reported as (b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.Part: 04.038.005s; lot: 42p9455; manufacturing location: (b)(4).Manufacturing date: march 31, 2020.Expiration date: march 01, 2030.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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 locking screw.This is report 4 of 4 for (b)(4).

• Brand Name: TI END CAP FOR TFNA 5MM EXTN - STERILE
• 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: 14026924
• MDR Text Key: 291818884
• Report Number: 8030965-2022-02230
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652118
• UDI-Public: (01)07611819652118
• 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: Physician
• Type of Report: Initial

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: 04.038.005S
• Device Lot Number: 42P9455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L36 F/NAILS TAN; TFNA FEM NAIL Ø12 130° L200 TIMO15; TFNA HELICAL BLADE L110 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 75 KG