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

Catalog Number UNK - NAIL HEAD ELEMENTS: FNS

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer 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.Brand name, common device name, manufacturer name, city and state, lot #, pma/510k: this report is for an unknown device/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter coccupation: reporter is a j&j sales representative.Lot #, mfr site, device manufacture date: the lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.Device evaluated by mfr and manufacturer date: without a lot number the device history records review could not be completed.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.

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: this is report 3 of 4 for (b)(4).It was reported by the sales rep in japan that a patient underwent an open reduction internal fixation surgery with the fns devices for the fracture of the femoral neck on (b)(6) 2022.It was reported that the surgery was completed successfully without any surgical delay.However, after the surgery, the patient complained of pain; and the examination confirmed that an internal deformity of the bone head had occurred.The revision surgery with removing the fns and the bipolar hip arthroplasty was reported to be performed.No additional information was provided.This complaint involves four (4) devices.

• Brand Name: UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 14518109
• MDR Text Key: 293266846
• Report Number: 8030965-2022-03556
• 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,Health Professional,User Facility,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: 05/26/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention