MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA RICHARD-ALLAN NEEDLE 1/2 CIRCLE TROCAR POINT MAYO CATGUT; SURGICAL NEEDLE

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/10/2018

Event Type  Injury  

Manufacturer Narrative

No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

Aspen surgical received a medwatch report (mw5079151) from the fda indicating that a 1/2 circle point needle broke during a procedure.The incident occurred at the user facility.This report was filed in our complaint handling system as (b)(4).

Event Description

Aspen surgical received a medwatch report (mw5079151) from the fda indicating that a 1/2 circle point needle broke during a procedure.The incident occurred at the user facility.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

Aspen surgical received a medwatch report (mw5079151) from the fda indicating that a 1/2 circle point needle broke during a procedure.The actual device was available for evaluation.No manufacturing lot number was provided for review.The end user indicated during a surgery for a left knee arthroscopically aided anterior cruciate ligament reconstruction with patella tendon autograft, left knee medial meniscus root repair, and left knee mcl repair, the surgeon was using a richard-allan needle 1/2 circle trocar point mayo catgut that broke.As the surgeon was suturing the mcl, it was noted on one of the passages that the needle had broken.It was removed in its entirety.A flat plate x-ray was obtained and noted to have complete removal of the needle.Wounds were then irrigated with normal sterile saline.The x-ray confirmed no foreign body was identified.There was no harm to the patient.Due to no manufacturing lot number available, a dhr review could not be performed.A review of the samples confirmed the reported issue for the broken needle.Inspection of the needle identified clamp marks close to the eye of the needle that was broken.According to aspen surgical's ifu, the needles should not be clamped directly on the eye of the needle to the point and should be applied to the flat portion of the needle about 1/4 of the needle length from the eye end.Therefore, a likely root cause could be attributed to operational error.With no lot number available, further investigation could not be performed.Based on this information, no further action is required.

• Brand Name: RICHARD-ALLAN NEEDLE 1/2 CIRCLE TROCAR POINT MAYO CATGUT
• Type of Device: SURGICAL NEEDLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• MDR Report Key: 7886596
• MDR Text Key: 120640649
• Report Number: 1836161-2018-00098
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention