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

Model Number	04.038.000S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 8030965-2022-02844
• Device Sequence Number: 5026183
• Product Code: HSB
• UDI-Device Identifier: 10886982098344
• UDI-Public: 10886982098344
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN; TFNA FEM NAIL Ø11 125° L200 TIMO15; TFNA FENESTRATED HELICAL BLADE 90 - SILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 55 KG