MAUDE Adverse Event Report: ARTHROCARE CORPORATION SPEEDSCREW 5.5MM PEEK KNOTLESS FIXATION IMPLANT; SCREW, FIXATION, BONE

Model Number OM-6500

Device Problems Entrapment of Device (1212); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/06/2021

Event Type  malfunction  

Event Description

A tiny little piece of metal that was apart of the arthrex suture anchor that was placed for brawstrom procedure that failed was left in because the removal process would have done more damage than good.

• Brand Name: SPEEDSCREW 5.5MM PEEK KNOTLESS FIXATION IMPLANT
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 w william cannon dr; austin TX 78735
• MDR Report Key: 13342020
• MDR Text Key: 284363402
• Report Number: 13342020
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2022,11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OM-6500
• Device Catalogue Number: OM-6500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2022
• Date Report to Manufacturer: 01/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: Native Hawaiian Or Other Pacific Islander