MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: TFNA; ROD, FIXATION, INTRAMEDULLARY

Device Problems Crack (1135); Unstable (1667)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Report is for an unknown nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.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.(b)(4).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) 2022, the patient underwent the open reduction internal fixation with the tfna nail for the fracture of the trochanteric femur.In this case, the posterior part was cracked and unstable.The surgeon did reduction on the traction table without a medical elevator.The surgery was completed successfully without any surgical delay.The x-ray was confirmed that proximal bone fragment turned, and there was a possibility of cut-out.Therefore, the tfna will be removed, and the bipolar hip arthroplasty will be performed on (b)(6) 2022.The surgeon requested that what kind of intraoperative measures could be taken to prevent such complications in this case of unstable fracture.No further information is available.This report is for one (1) unk - nails: tfna.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - NAILS: TFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13839274
• MDR Text Key: 287535041
• Report Number: 8030965-2022-01778
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• 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: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 60 KG