MAUDE Adverse Event Report: SYNTHES GMBH TFNA END CAP EXTENS. 0 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.038.000S

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Product complaint number: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.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.Part: 04.038.000s, lot: 272p826, manufacturing site: (b)(4).Release to warehouse date: 26 july 2021.Expiry date: 01 july 2031, a manufacturing record evaluation was performed for the finished article lot 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.

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 an open reduction internal fixation with the trochanteric fixation nail- advanced for the fracture of the diaphyseal femur.The surgery was completed successfully without any surgical delay.After the surgery, secondary fracture had occurred.A tfna fenestrated helical blade 90mm ¿ sterile, tfna femoral nail ø11 125° l200 timo15, lockscrew ø5 l34 f/nails tan- light green, and a tfna end cap extension 0 tan were used during the procedure.On (b)(6) 2022, the revision surgery was performed to remove the trochanteric fixation nail- advanced and fix the fracture with a long gamma nail and screws.According to the surgeon, this event was caused by a technical error due to poor implant insertion point, not product malfunction.The surgeon thought that the patient had not fallen.The surgeon guessed that the secondary fracture may be a stress fracture because the insertion point was posterior, and the tip of nail was hitting the anterior cortical bone.No further information is available.The procedure was successfully completed.The patient outcome is reported as stable.This report is for one (1) tfna end cap extension 0 tan.This is report 1 of 4 for complaint (b)(4).

• 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 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14254635
• MDR Text Key: 290456436
• Report Number: 8030965-2022-02844
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982098344
• UDI-Public: 10886982098344
• 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

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.038.000S
• Device Catalogue Number: 04.038.000S
• Device Lot Number: 272P826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN; TFNA FEM NAIL Ø11 125° L200 TIMO15; TFNA FENESTRATED HELICAL BLADE 90 - SILE
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 55 KG