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 Code Available (3191)

Event Date 12/14/2017

Event Type  Injury  

Event Description

Customer reported that during a procedure, the eye of the needle broke for item number 216705 and required retrieval using x-ray.

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 was prolonged to retrieve the broken section of needle.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.Two needles were returned from lot 144680.One needle was broken at the tip of the eye.The other needle was intact.The unbroken needle had clamping marks around the needle towards the middle section of the needle and down towards the point.The broken needle had clamping marks that were very close to the point of the needle.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: 7179604
• MDR Text Key: 96884648
• Report Number: 1836161-2018-00003
• 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: consumer,health professional
• 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

• Date FDA Received: 01/10/2018
• 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: 144680
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2017
• 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