MAUDE Adverse Event Report: SMITH NEPHEW, INC. OSTEORAPTOR; SCREW, FIXATION, BONE

Model Number 72201995

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 04/04/2022

Event Type  malfunction  

Event Description

Osteoraptor 2.9 suture anchor with two ultrabraid failed during insertion to left shoulder.Sales representative was in the room.The surgeon recognized the failure immediately and replaced it with a new osteoraptor.Manufacturer response for suture anchor, osteoraptor (per site reporter) no response.

• Brand Name: OSTEORAPTOR
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 15893001
• MDR Text Key: 304594032
• Report Number: 15893001
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/21/2022,08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201995
• Device Catalogue Number: 72201995
• Device Lot Number: 2080577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2022
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA