MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT; POLYPROPYLENE 4-0 BLUE 1X18" P-3

Model Number	J8699N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records for the reported finished good lot and raw material components identified no quality issues during the incoming, manufacturing, in-process, or final inspection processes.The actual sample was not returned for review.No photos of the surgical site or device when removed from the patient was forwarded for review.If samples or photos become available at a later time, they will be reviewed, and the results will be included in the complaint file.A follow-up report will be submitted at that time.Two (2) sterile retained samples from the same finished good lot were available for testing/visual examination.No defects or abnormalities were observed during the visual review.The devices met all specification including the usp tensile and needle pull requirements.The bending, fracturing, breaking of a needle can occur when needles are gripped with a needle holder, forceps, or some type of 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 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 mentioned above.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.Without receiving the actual sample to review under the microscope, receiving magnified photos of the actual device and/or surgical site or receiving detailed the preoperative preparation of the devices, procedure performed, tools utilized to grasp the device, a definitive root cause cannot be determined at this time.
Event or Problem Description
The needle tip of the product broke off and was in the patient¿s surgical site.The patient was sent to the hospital to have the needle located so that the needle could be removed from the surgical site.No patient injury reported.

• Brand Name: SHARPOINT
• Common Device Name: POLYPROPYLENE 4-0 BLUE 1X18" P-3
• 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; 1100 berkshire blvd.; ste 308; reading PA 19608
• Manufacturer Contact: kelly knappenberger ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 18824104
• Report Number: 3010692967-2024-00016
• Device Sequence Number: 7878793
• Product Code: GAW
• UDI-Device Identifier: 10848782016812
• UDI-Public: (01)10848782016812(17)270108(10)C209LMZ
• Combination Product (Y/N): N
• PMA/510(K) Number: K131224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2024
• Report Date (Section F): 02/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: J8699N
• Device Catalogue Number: J8699N
• Device Lot Number: C209LMZ
• Was the Report Sent to FDA?: No
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown