MAUDE Adverse Event Report: PARCUS PARCUS 45 KNOTLESS 4.5MM PEEK ANCHOR; ROTATOR CUFF ANCHOR

Model Number 45 KNOTLESS 4.5MM PEEK ANCHOR

Device Problem Detachment Of Device Component (1104)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 03/29/2017

Event Type  Injury  

Event Description

Pt had arthroscopic rotator cuff repair (b)(6) 2016 using parcus 45 knotless 4.5mm peek anchors (1 anchor), lot 6246, expiration 05/12/2020, ref #(b)(4).Pt had continued pain and limited range of motion, so repeat mri was done (b)(6) 2017 and showed anchors had backed out and were 'proud' to the cortex.They were removed on (b)(6) 2017 and pt has thus far progressed very well.

• Brand Name: PARCUS 45 KNOTLESS 4.5MM PEEK ANCHOR
• Type of Device: ROTATOR CUFF ANCHOR
• Manufacturer (Section D): PARCUS
• MDR Report Key: 6710515
• MDR Text Key: 80063029
• Report Number: MW5070953
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2017

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: No Information
• Device Expiration Date: 05/12/2020
• Device Model Number: 45 KNOTLESS 4.5MM PEEK ANCHOR
• Device Lot Number: 6246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR