MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 95MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.395S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the tfna helical blade cut out the femoral head.The patient underwent the open reduction internal fixation for the trochanteric fracture of the femur with the tfna in question on (b)(6) 2021.The surgery was completed successfully without any surgical delay.The surgeon commented that the anterior part of the femoral neck was slightly cracked and slightly medially fractured.As a result, bone healing was delayed and the femoral head rotated that might have caused cut-out the femoral head.The patient had difficulty walking due to pain after the surgery.The implant was removed from the body and the patient underwent the bipolar hip arthroplasty on (b)(6) 2021.No further information is available.This report is for one (1) tfna fenestrated helical blade 95mm - sterile.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

Additional procode: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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 lot: part # 04.038.395s, lot # 50p5511, manufacturing site: (b)(4), release to warehouse date: 30 mar2020, expiration date: 01 mar2030, supplier: synthes usa hq, inc.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.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 95MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13315076
• MDR Text Key: 284289835
• Report Number: 8030965-2022-00474
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652583
• UDI-Public: (01)07611819652583
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.395S
• Device Lot Number: 50P5511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L36 F/NAILS TAN; TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL Ø12 125° L170 TIMO15
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 65 KG