MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 90MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.390S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 01/01/2022

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.Date of event is an unknown date in 2022.Additional procode: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4) / packaged, sterilized and released by: monument manufacturing date: july 22, 2021.Expiration date: july 01, 2031.Part: 04.038.390s, tfna fenestrated helical blade 90mm -sterile.Lot: 270p543 (sterile).Note: helical blade was manufactured by (b)(4); lots 239p793 / 252p897.Parts were packaged, sterilized, and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) supplied by (b)(4) was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent osteosynthesis for fracture of the trochanteric femur with the trochanteric fixation nail advanced (tfna) system and augmentation.The surgeon exfoliated the iliofemoral ligament and performed extramedullary reduction with a custom-made elevator.The surgeon inserted the tfna nail, the blade, and the cement.The surgery was completed successfully without any surgical delay.The patient started to load-bear from the day after surgery; postoperative x-rays showed no defects.Postoperative x-rays taken on (b)(6) 2022, also showed no defects.On (b)(6) 2022, the patient was walking on their own and was moved to a nursing facility.The patient complained of pain.Cut-out was confirmed on (b)(6) 2022.Circumstances are unknown however, there is a possibility that patient may have fallen, as there are symptoms of a fall on the patient¿s face and other parts of the body.The patient denies having fallen.This report is for a tfna fenestrated helical blade 90mm - sterile.This is report 2 of 3 for (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 90MM - 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14058893
• MDR Text Key: 291820859
• Report Number: 8030965-2022-02335
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652576
• UDI-Public: (01)07611819652576
• 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: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.390S
• Device Lot Number: 270P543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TFNA FEM NAIL Ø11 125° L200 TIMO15; UNK - BIOMATERIAL - CEMENT: TRAUMACEM
• Patient Outcome(s): Required Intervention
• Patient Age: 97 YR
• Patient Sex: Male