MAUDE Adverse Event Report: LINVATEC BRANDED UNITS SHUTT-LINVATEC; CRESCENT SPECTRUM/SUTURE PASSER

Model Number 4MM X 20MM

Device Problem Break (1069)

Patient Problems Pain (1994); Tingling (2171); Numbness (2415)

Event Date 08/29/2016

Event Type  Other  

Event Description

This pt was having right shoulder arthroscopy surgery.During the case, the doctor was passing the sutures through the labrum and capsule using the spectrum crescent, he performed 3 without any complications.However, in the process of passing the 4th suture using the crescent spectrum tip broke off and had to be recovered using fluoroscopy during the surgical case.The crescent spectrum tip was recovered using fluoroscopic imaging in the operating room.Right posterior shoulder pain with occasional numbness and tingling of right arm.

• Brand Name: SHUTT-LINVATEC
• Type of Device: CRESCENT SPECTRUM/SUTURE PASSER
• Manufacturer (Section D): LINVATEC BRANDED UNITS; largo FL 33773
• MDR Report Key: 5966056
• MDR Text Key: 55378194
• Report Number: MW5064871
• Device Sequence Number: 1
• Product Code: HWQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/19/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: 4MM X 20MM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 77