MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK - NAIL HEAD ELEMENTS: FNS

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

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

Event Type  Injury  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: this is report 4 of 4 for (b)(4).It was reported by the affiliate in (b)(6) that on (b)(6) 2022, the patient underwent an open reduction internal fixation procedure with the fns for the fracture of the femoral neck.According to the report, the surgery was completed successfully without any surgical delay.However, it was reported that after the surgery, bone healing failed.Therefore, removal of the fns and the bipolar hip arthroplasty was scheduled on (b)(6) 2022 but was later cancelled due to a patient¿s urgent request to be transferred to a different hospital.The current status of the patient was unknown.No additional information was provided.This complaint involves four devices.

Manufacturer Narrative

Additional narrative: 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.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j employee.Without a lot number the device history records review could not be completed.(b)(4).Investigation summary: 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.

• Brand Name: UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14489296
• MDR Text Key: 292520246
• Report Number: 8030965-2022-03396
• 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
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - NAIL HEAD ELEMENTS: FNS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention