MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. RICHARD-ALLAN FREE NEEDLE; NEEDLE, SUTURING, DISPOSABLE

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  Injury  

Event Description

During a quadriceps repair, sutures from swivelock anchors were used to re-imbricate the repair, and a suture needle broke.The suture needle was removed in its entirety, and an intraop xray was done confirmed no retained foreign objects.Fda safety report id # (b)(4).

• Brand Name: RICHARD-ALLAN FREE NEEDLE
• Type of Device: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.
• MDR Report Key: 10884747
• MDR Text Key: 217966325
• Report Number: MW5098023
• Device Sequence Number: 1
• Product Code: GAB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR