MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO S. DE. R.L. DE C.V. STRATAFIX; 2RB-1 3-0 U MND 16X16 13MM LDR

Model Number	SXMD2B403
Health Effect - Clinical Code	Failure to Anastomose (1028)
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 no samples or photos of the surgical site were available for review.There were no retained samples available for review.If samples, or additional information become available at a later date, the samples or information will be reviewed and added to the file and a follow-up report will be filed.Without receiving sterile devices to review/test, receiving photos of the surgical site 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, post-operative events that may have occurred that may have affected the outcome of the surgery, details regarding the training, experience or technique of the surgeon with the use of the barbed device(s) or robotic surgeries, a definitive root cause for the reported event cannot be confirmed with certainty.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.The warning in the ifu states, ¿this an absorbable material, the use of supplemental non absorbable sutures should be considered by the surgeon in the closure of sites which may undergo expansion, stretching or distention or which may require additional support.
Event or Problem Description
The end user reported to our distributor there was anastomosis of urethra.The device came loose postoperatively (anastomosis insufficiency).Additional information received indicated the patient was compliant with post-op instructions.The patient is reported to be doing fine.
Additional Manufacturer Narrative
The actual device was not returned for review.No retained samples or photos are available for testing/review.If samples/photos become available, they will be reviewed, and the results will be included in the file.A revised response will be forwarded to you at that time four (4) sterile samples from the finished good lot were received and visually evaluated.No defects or abnormalities were observed on the packages or device(s).The samples met specification including the tensile requirements for a monoderm devices.Without receiving photos of the surgical site/device 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, post-operative events that may have occurred that may have affected the outcome of the surgery , details regarding the training, experience or technique of the surgeon with the use of the barbed device(s) or robotic surgeries, a definitive root cause for the reported event cannot be confirmed with certainty.
Additional Manufacturer Narrative
Additional information from our distributor indicated the patient is doing fine.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 no samples or photos of the surgical site were available for review.There were no retained samples available for review.If samples, or additional information become available at a later date, the samples or information will be reviewed and added to the file and a follow-up report will be filed.Without receiving sterile devices to review/test, receiving photos of the surgical site 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, details regarding the training, experience or technique of the surgeon with the use of the barbed device(s) or robotic surgeries, a definitive root cause for the reported event cannot be confirmed with certainty.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.The warning in the ifu states, ¿this an absorbable material, the use of supplemental non absorbable sutures should be considered by the surgeon in the closure of sites which may undergo expansion, stretching or distention or which may require additional support.

• Brand Name: STRATAFIX
• Common Device Name: 2RB-1 3-0 U MND 16X16 13MM LDR
• 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; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 02090 ; MX 02090
• Manufacturer Contact: luis jauregui giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 15629714
• Report Number: 3010692967-2022-00047
• Device Sequence Number: 20818629
• Product Code: GAM
• UDI-Device Identifier: 10705031208100
• UDI-Public: (01)10705031208100(20)17(17)270531(10)C629MSZ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2022
• Report Date (Section F): 10/10/2022

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: SXMD2B403
• Device Lot Number: C629MSZ
• Was the Report Sent to FDA?: No
• Event Location: Other
• Date Report to Manufacturer: 10/10/2022
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 10/18/2022; 10/18/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 10/25/2022; 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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; Other
• Patient Sex: Unknown