MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN CANNULATED SCREWS SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNKN02200702

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

Patient Problems Necrosis (1971); Non-union Bone Fracture (2369)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4). Zhu, z. D. , xiao, c. W. , tan, b. , tang, x. M. , wei, d. , yuan, j. B. ,. & feng, l. (2021). Tirobot-assisted percutaneous cannulated screw fixation in the treatment of femoral neck fractures: a minimum 2-year follow-up of 50 patients. Orthopaedic surgery, 13(1), 244-252. Doi: 10. 1111/os. 12915.

Event Description

On the literature article named "tirobot-assisted percutaneous cannulated screw fixation in the treatment of femoral neck fractures: a minimum 2-year follow-up of 50 patients", it was reported that, after cannulated screws screw had been implanted on 3 patients, after conventional internal fixation surgery using three 7. 3 mm diameter cannulated screws to treat an unilateral femoral neck fracture, 3 patients reported delayed fracture union in a time frame of 4-8 months postoperatively, which later developed in avascular necrosis of the femoral head. Further details on how was this adverse event treated are unknown.

• Brand Name: UNKN CANNULATED SCREWS SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12623759
• MDR Text Key: 276137927
• Report Number: 1020279-2021-07546
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKN02200702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/13/2021 Patient Sequence Number: 1