MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; CT-1 0 PDO 30CM

Model Number	SXPD1B401
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information and photos were provided by the distributor for a complaint initially reported without incident.It was reported that there was a problem with the needle pulling off the suture and it fell into the patient.The needle was eventually located and removed indicating a delay in surgery time.
Additional Manufacturer Narrative
A batch review of the finished good lot and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, in-process or final inspection process.The needle is an ethicon supplied component.No sterile devices or retained samples were available for testing or review.If the samples become available at a later time, a follow-up report will be submitted at that time.The customer provided two pictures with the complaint form.The device was observed within a plastic bag.The needle is loose from the suture.There is a remnant of suture jutting from the needle hole indicating the suture broke near the swaged end of the needle, not detached as reported.The loop/weld remained intact; no unusual damage observed.A clear analysis of the device could not be performed as the photo became distorted when magnified.The actual sample was returned with the foil package labeled as lot: aafu859.The device appears used (ex.Blood, engaged barbs).No damage was observed on the needle component.The needle was loose from the suture.A frayed suture remnant was protruding from the needle hole indicating the device did not pull free from the suture; the suture broke near the attachment.The end point of failure on the suture appeared elongated, frayed, sheared up the side of the device.The barbs were engaged; no unusual damage was observed on the suture strand.The loop/weld remained intact; no unusual damage observed.The needle detaching from the suture most likely occurred due to the device being gripped on or near the swaged end of the needle by the needle holder, forceps, and/or surgical instrument, damaging the suture allowing the needle to break free from the suture.It''s also possible the suture broke near the attachment due to excessive force being utilized, exceeding the tensile strength of the suture, allowing the suture to break during the procedure.The precautions section of the ifu for the stratafix¿ 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, swage areas and attachments, 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 sterile devices from the same finished good lot to test/review, or receiving detailed information regarding the preoperative preparation of the device, tools utilized to grasp the device(s), procedure(s) performed, or the surgeon¿s technique, a definitive root cause cannot be determined at this time.

• Brand Name: STRATAFIX
• Common Device Name: CT-1 0 PDO 30CM
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V.; corredor tijuana rosarito 2000; 24702 b, ejido francisco villa; tijuana ; MX
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis jauregui giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 15499788
• Report Number: 3010692967-2022-00041
• Device Sequence Number: 20356031
• Product Code: NEW
• UDI-Device Identifier: 10705031227941
• UDI-Public: (01)10705031227941(20)12(17)250228(10)AAFU859
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2022
• Report Date (Section F): 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: SXPD1B401
• Device Lot Number: AAFU859
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/22/2022
• Device Age: 30 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2022
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown