MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT; DS18 4-0 BK MONO NYLON 18"/45CM

Model Number AC-0182D

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

Method - the broken device was discarded by the end user.No sterile samples have been received to date.Results - no samples were returned for testing / review.There is no available stock of lot aabl227.Relevant portions of the device history record were reviewed.The product from the finished good lot and all components met current usp and surgical specialties mexico requirements throughout the incoming, manufacturing, in-process and final inspection processes.Without receiving the actual re-sterilized device for review, sterile samples for ductility testing or receiving detailed information regarding the pre-operative preparations of the needle device, procedure or the surgeon's technique, a definitive root cause for the needle breaking during the procedure cannot be determined with certainty.

Event Description

The needle broke during a back/skin lesion extrusion from upper right quad.The tip of the device could not be located.Patient sent for xray to locate the needle.The piece was removed without injury or harm to the patient.The patient was taken back to surgery to close incision.

Manufacturer Narrative

Ten (10) sterile samples were returned and visually examined under 20 % magnification and ductility tested per the specified requirements for this size/type needle component.All results were acceptable per the 45deg.Bend test and no defects were noted during the visual review.Without receiving specifics regarding the pre-operative preparation of the device, type or size needle driver utilized in conjunction with the device, or location on the needle where it was grasped with the driver, a definitive root cause for the needle breaking during the procedure cannot be determined at this time.The bending or fracturing of a needle can occur when needles are gripped with a needle holder/forceps at the swaged area and/or near the tip of the device.The stress at the gripped area may exceed the maximum stress of the material resulting in bending and/or failure (broken needle).The stress on the attachment section is greatly reduced when the needle is held in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point as indicated in the ifu for this product.

• Brand Name: SHARPOINT
• Type of Device: DS18 4-0 BK MONO NYLON 18"/45CM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; 24702-b, ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 7530971
• MDR Text Key: 109030380
• Report Number: 3010692967-2018-00009
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): Y
• PMA/PMN Number: K903029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: AC-0182D
• Device Catalogue Number: AC-0182D
• Device Lot Number: AABL227
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 04/20/2018
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR