MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.102 STERILE; SURGICAL NEEDLE

Model Number 216705

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Information (3190)

Event Date 11/29/2017

Event Type  Injury  

Event Description

During shoulder surgery, a piece of item number 216705 broke from the needle.

Manufacturer Narrative

Aspen surgical performed a follow-up with the customer.The actual device was determined to be available for evaluation.The manufacturing lot number was also provided for review.The end user indicated that during a shoulder surgery, the eye section of the needle separated from the needle.Using x-ray guidance the surgeon was able to located and retrieve the detached eye section of the needle.Surgery time was prolonged.The patient tolerated well and follow up care was not required.Analysis result of the finished good lot number and incoming inspections of the raw material were reviewed.All samples passed acceptance criteria.No non-conformance's were noted in the dhr.Four needles were returned from lot 108328.Three needles were broken at the eye of the needle.One needle was intact.The broken needles have clamp marks around the needles closest to the eye and point.The unbroken needle does not have any marks on it.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.A review of the samples returned show that the needles were clamped improperly either not on the flat side or too close to the eye or point, which likely caused them to break.Based on this information, the root cause is attributed to customer misuse and no further action is required.

Event Description

Aspen surgical received a report from the end user indicating that the eye of a 1/2 circle taper point needle separated during a procedure.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT .050X1.102 STERILE
• Type of Device: SURGICAL NEEDLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 7137706
• MDR Text Key: 95495434
• Report Number: 1836161-2017-00135
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 216705
• Device Lot Number: 108328
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention