MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 2CTX #2 PDO 36 X 36

Model Number	SXPD2B405
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
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, sterilization, in-process, or final inspection process.The actual device or photos were not provided for review, if samples, photos or additional information become available at a later date, the samples, photos or information will be reviewed and results will added to the file.A sterile sample was returned for visual review/testing.No defects or abnormalities were observed on the package or the device.The devices met all current requirements for a #2 pdo device.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 wound opening, sutures failing 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, obesity, premature post-surgery exercise and heavy lifting.Without receiving photos of the surgical site/broken device or receiving detailed information regarding the method utilized to anchor the device in the tissue, the patient¿s health status (age, weight) and quality of the tissue, details regarding post-operative activity, physical therapy or injuries or falls that may have occurred, number of days the device remained in the body, a definitive root cause for the reported event cannot be confirmed with certainty.
Event or Problem Description
Sales rep reported that dr.(b)(6) had to bring patient back that he performed a total knee on because knee capsule had shifted to the side.He opened knee up to find stratafix broken in the middle.He went to fix the issue pulled another stratafix and starting sewing and the suture broke.No patient harm.

• Brand Name: STRATAFIX
• Common Device Name: 2CTX #2 PDO 36 X 36
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V.; corredor tijuana rosarito 2000; 24702 b, ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; suite ne1; westwood MA 02090
• Manufacturer Contact: ronald giannangelo ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 17821312
• Report Number: 3010692967-2023-00040
• Device Sequence Number: 12302465
• Product Code: NEW
• UDI-Device Identifier: 10705031207981
• UDI-Public: (01)10705031207981(20)16(17)280331(10)D412EUV
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2023
• Report Date (Section F): 09/01/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: SXPD2B405
• Device Lot Number: D412EUV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/25/2023
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 09/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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: Other; Required Intervention
• Patient Sex: Unknown