MAUDE Adverse Event Report: ARTHROCARE CORPORATION UNKN SPORTS MEDICINE SUTURE DEV; ACCESSORIES,ARTHROSCOPIC

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a knee arthroscopy, it was noted that the acufex device that was being used was broken after removing it from the patient's knee.The doctor was concerned it could have left a broken piece of the instrument inside the patient's knee, therefore, x-ray was done and confirmed there was no metal/ broken piece of the instrument in the patient's knee.The broken instrument was examined at the end of the case, the doctor did not think there were any pieces of instrument that broke off inside the patient.It is unknown if there was a back-up device available or if there was a delay.No further complications were reported.

• Brand Name: UNKN SPORTS MEDICINE SUTURE DEV
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19193337
• MDR Text Key: 341178092
• Report Number: 3006524618-2024-00162
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male