MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT; NYLON 4-0 PS2

Model Number	A1667S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
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 devices or magnified photos were not returned for review.No sterile devices were received from the end user (rma 44394).If samples are received at a later time, they will be reviewed and tested, and the results will be included in the file.A revised response will be forwarded to you at that time.Sterile samples from lot aafs047 were available in our stock.The samples were visually reviewed and tested.No defects or abnormalities were observed on the packages or devices.The devices met current specification including the usp tensile strength requirements for a 4-0 nylon device.The suture breaking during use most likely resulted from the interaction of specific procedural related stress in contrast to the suture strength.It¿s also possible the devices are being grasped with surgical instruments and/or forceps, damaging the suture, allowing the device to break/snap during use.The ¿precautions¿ section in the ifu for the device states, ¿care should be taken to avoid damage when handling.Avoid crushing or crimping the suture material with surgical instruments such as needle holders and forceps.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¿.Without receiving the decontaminated, actual device(s) for review, receiving magnified photos of the used devices for review, receiving sterile devices from the end user for visual review/testing, or receiving details regarding the method utilized to remove the device from the packaging, preoperative preparation of the device(s), tools utilized to grasp the device(s), or procedures performed, a definitive root cause cannot be determined at this time.
Event or Problem Description
Samples provided by rep for trialing - we had one case (excision) where the dr.Closed the patient up and they were cleaning patient up and the sutures completely popped.She had to re- stitch the patient up with a different brand.
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 devices or magnified photos were not returned for review.No sterile devices were received from the end user (rma 44394).If samples are received at a later time, they will be reviewed and tested, and the results will be included in the file.A revised response will be forwarded to you at that time.Sterile samples from lot aafs047 were available in our stock.The samples were visually reviewed and tested.No defects or abnormalities were observed on the packages or devices.The devices met current specification including the usp tensile strength requirements for a 4-0 nylon device.The suture breaking post-operative most likely resulted from the interaction of specific procedural related stress in contrast to the suture strength.As stated in the ifu for the devices, ¿adverse events including wound dehiscence and reactions are common risks/complications of any surgical procedure.There are many causes that can result in the sutures failing, dehiscence or reaction, infection, abscess/leakage during or post-operative a procedure: the patient¿s health status, poor skin quality, thin skin; the risk is higher with a patient with a weak immune system, malnutrition, or chronic medical condition.The surgical procedure ¿ the risk increases with poor surgical techniques such as improper suturing, over-tightened sutures or inappropriate type of suture used for a particular procedure.Other factors - the risk is greater with smoking, or obesity.Without receiving photos of the actual device/incision/surgical site, receiving sterile devices from the customer to review/test, or receiving detailed information regarding the pre-operative preparation of the devices, placement of the device in the tissue, method utilized to secure the device in the tissue as stated in the ifu, the patient¿s specifics, quality of the tissue where suture was placed, a definitive root cause for the reported event cannot be confirmed with certainty.

• Brand Name: SHARPOINT
• Common Device Name: NYLON 4-0 PS2
• 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: 17191931
• Report Number: 3010692967-2023-00025
• Device Sequence Number: 7413262
• Product Code: GAR
• UDI-Device Identifier: 00848782032372
• UDI-Public: (01)00848782032372(17)250228(10)AAFS047
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023
• Report Date (Section F): 05/08/2023

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 Expiration Date: 02/28/2025
• Device Model Number: A1667S
• Device Catalogue Number: A1667S
• Device Lot Number: AAFS047
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/28/2023
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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