MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: PFNA BLADE ROD, FIXATION, INTRAMEDULLARY

Catalog Number UNK - NAIL HEAD ELEMENTS

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: this is report 2 of 4 for (b)(4). It was reported that on april 1, the patient underwent the open reduction internal fixation with the pfna for the fracture of the trochanteric femur on unknown date. It was reported that the surgery was completed successfully without any surgical delay. However, after the surgery, pseudoarthrosis had occurred. It was reported that the revision surgery with removal of the pfna and the bipolar hip arthroplasty was performed on (b)(6) 2022. According to the surgeon, the patient had a medical history of acth deficiency and diabetes mellitus and was taking steroids. It was reported that the use of steroids might have made it difficult to achieve bone healing that might cause pseudoarthrosis. This event was not due to the implants malfunction. No further information is available. This report is for one (1) unk - nail head elements: pfna blade device. This complaint involves four (4) devices.

Manufacturer Narrative

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. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j employee. The lot number was unknown. Therefore, the expiration date and device manufacture date were unknown. 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. 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: UNK - NAIL HEAD ELEMENTS: PFNA BLADE
• 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: 14223299
• MDR Text Key: 290270035
• Report Number: 8030965-2022-02752
• 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

• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK - NAIL HEAD ELEMENTS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 04/27/2022 Patient Sequence Number: 1