MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT; 2VSP8 6-0 VIO BR PGA 18"/45CM

Model Number G555N

Device Problem Dull, Blunt (2407)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

The lot number of the device used for this procedure was not disclosed by the end user.A review of the device history record could not be performed.The needle was not returned from the end user for review.Magnified photos of the device have not been received for review.Complaints will continue to be monitored.Previous research has shown that the bending, fracturing, breaking of a needle can occur when needles are gripped with a needle holder, forceps, or surgical instrument on or near the swaged area or near the tip of the device, when excessive force is applied, when the device(s) are used in applications involving tortuous tissue or with a needle tip design that may not be appropriate for the specific tissue or procedure.The report of a dull needle can be the result of a damaged tip, cutting edge, or apex.A needle that features a long thinner tip can easily become damaged during the manufacturing process or during use.A damaged needle would most likely be detected during one of the in-process inspection points or during the final inspection process however the inspection process is based on a sampling plan, which represents the lot; it is not a 100% inspection of the entire lot.Damage to the needle component has occurred when removing the device from the protective foam, wrapping card or while preparing the device for the procedure.The needle edges and points can be damaged very easily if dropped, bumped or come in contact with any hard, rough surface, or if grasped incorrectly with a needle holder or forceps.The ¿precaution¿ section in the ifu for this product states, ¿to avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point¿.

Event Description

Samples requested for trial-needles have been reported as dull and break easily.The surgeon had a very hard time getting it to go through the area and ended up puncturing the globe (eye).Additional questions sent regarding details or the procedure performed, intervention, patient health history/current status via the company representative.No details could be obtained to date.

• Brand Name: SHARPOINT
• Type of Device: 2VSP8 6-0 VIO BR PGA 18"/45CM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702 b, ejido franciso villa; tijuana baja california 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; suite ne1; westwood MA 02090
• Manufacturer Contact: kelly knappenberger ; corredor tijuana-rosarito 2000; #24702b ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 19076823
• MDR Text Key: 339777860
• Report Number: 3010692967-2024-00021
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K965162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2024,04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G555N
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/29/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2024
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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