MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA NEEDLE 1/2 CIRCLE TROCAR POINT MAYO CATGUT .050X1.260 STERILE; SURGICAL NEEDLE

Model Number 217004

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Aspen surgical received a report from the end user indicating that a needle broke during a procedure.An additional report was also received from the fda from the mail identifying this complaint and the issue from the end user.The actual device was not available for evaluation.The manufacturing lot number and photographic evidence was provided for review.The end user indicated that a 1/2 circle trocar point mayo catgut needle broke at the base of the eye section during a cervical cerclage procedure.The surgeon was unable to locate and retrieve the shaft section of the needle.The patient required follow ups with ultrasounds to monitor for the needle.Analysis result of the finished good lot number 65467 and incoming inspections of the raw material were reviewed.All samples passed acceptance criteria.No non-conformance's were noted in the dhr.Photographic evidence confirmed the broken needle condition.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.Based on this information, due to no sample being returned, the root cause could not be determined and no further action is required.

Event Description

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

• Brand Name: NEEDLE 1/2 CIRCLE TROCAR POINT MAYO CATGUT .050X1.260 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: 7537946
• MDR Text Key: 109054951
• Report Number: 1836161-2018-00047
• 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
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 217004
• Device Lot Number: 65467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2014
• 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