MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; 2DE14 3-0 PDO 24 X 24

Model Number	RA-1052Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
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, sterilization or final inspection processes.An unopened sample from the reported finished good lot was returned from the operating hospital for review.The device met all requirements including the usp tensile strength requirements for a 3-0 pdo device.No defects or abnormalities were observed on the package or the seals.Pdo (polidioxanone) material is essentially absorbed between 182- and 238-days post implantation.However, this specific material has in vivo strength retention for up to six (6) weeks.All sutures are technically ¿foreign substances¿ that the human body has a tendency to reject.Ideally this means the body breaks them down and dissolves them over a period of 3 or 4 months.¿ 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 details or photographs of the incision/post-operative condition, or receiving pertinent details regarding the hospitals infection rate, procedures performed, patient''s health history''s, past reactions to suture materials or medications, relevant culture results, condition of the tissue where the devices are being placed, or the surgeon¿s technique, a definitive root cause cannot be determined at this time.
Event or Problem Description
The reporter mentioned that the hospital clinical feedback from (b)(6) this year began to use ra-1052q batch number aaib752, (b)(4) of the patients have an incision infection after suturing, the hospital side hoped we can provide the report to the hospital.I have checked the adrs system and found this case has not been reported.Based on limited complaint information, the end user performed orthopedic surgery, no video or photos provided.No cultures or results provided.The exact type of infection not identified.By contacting with the reporter and the hospital, they can provide an unopened suture for investigation.

• Brand Name: QUILL
• Common Device Name: 2DE14 3-0 PDO 24 X 24
• 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: 18157062
• Report Number: 3010692967-2023-00055
• Device Sequence Number: 6560305
• Product Code: NEW
• UDI-Device Identifier: 10848782019028
• UDI-Public: (01)10848782019028(17)260628(10)AAIB752
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/16/2023
• Report Date (Section F): 11/09/2023

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 Expiration Date: 06/28/2026
• Device Model Number: RA-1052Q
• Device Catalogue Number: RA-1052Q
• Device Lot Number: AAIB752
• Was the Report Sent to FDA?: No
• Device Age: 27 MO
• Event Location: Home
• Date Report to Manufacturer: 11/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• 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