MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE 80MM STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.280S

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

Patient Problem Bone Fracture(s) (1870)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent surgery for a trochanteric fracture with the products in question.The patient had dementia, so the date of injury and the starting point of injury are unknown.The tibia was fractured and immobilized in a cast.In the opinion of the surgeon, cast immobilization from the tibia to the distal femur resulted in a stress concentration between the tibia and the nail, resulting in a fracture distal to the nail.The patient's heart was too weak to be operated on, and it was decided not to perform the surgery again.The patient was reported as stable.No further information is available.This report involves one tfna helical blade 80mm sterile.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Only the event year is known.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Part # 04.038.280s.Synthes lot # 23p6436.Supplier lot # 23p6436.Release to warehouse date: 06 dec 2019.Supplier:monument.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.

• Brand Name: TFNA HELICAL BLADE 80MM 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: 15700238
• MDR Text Key: 302710626
• Report Number: 8030965-2022-09080
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,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: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.280S
• Device Lot Number: 23P6436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L32 F/NAILS TAN LIGHT GREEN.; TFNA FEM NAIL Ø10 125° L170 TIMO15.
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Sex: Female