MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT PLUS; PDO 3-0 VIOLET 1X18" PS-2

Model Number	R497N
Health Effect - Clinical Codes	Inflammation (1932); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeries performed with pdo have resulted in significant inflammation.I thought some was due to knot slippage and necessity of placing a 4th row and perhaps with slippage, the overtightening of the wound.I observed swollen wounds particularly with 3-0 pdo.
Additional Manufacturer Narrative
Additional lot ba06nzz manuf.Date 10/2/2021 exp.Date 10/6/2026.(b)(4).A review of the device history records for the finished good lots and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, in-process or final inspection processes.The sterility records were reviewed and met all requirements.Sterile product was returned for testing/review.The results of the evaluations are pending.The results will be submitted upon completion of the analysis.The "precautions" section of the ifu for the pdo device states, "infections, erythema, foreign body reactions, transient inflammatory reactions and in rare instances wound dehiscence are typical or foreseeable risks associated with any suture and hence are also potential complications associated with pdo devices.Without receiving details of the exact product used, procedures performed, placement of the device in the tissue, patient health history, type of intervention required, culture results and/or surgeon's technique, a definitive root cause cannot be determined at this time.
Additional Manufacturer Narrative
Sterile product was returned on 5/26/2022 for visual review/testing.The product met all specifications for this size/type suture.Lot #: ba27ssl, p/n: r497n, bar/udi code: (b)(4), mr¿s reported: n/a, sterilization: met all requirements.Ifu: ¿actions ¿ pdo (polydioxanone) suture is a monofilament that elicits a minimal acute inflammatory reaction during absorption.¿ lot #: ba06nzz, p/n: r497n, bar/udi code: (b)(4).Sterilization: met all requirements.Ifu: ¿actions ¿ pdo (polydioxanone) suture is a monofilament that elicits a minimal acute inflammatory reaction during absorption.¿.

• Brand Name: SHARPOINT PLUS
• Common Device Name: PDO 3-0 VIOLET 1X18" PS-2
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 14523475
• Report Number: 3010692967-2022-00016
• Device Sequence Number: 20124981
• Product Code: NEW
• UDI-Device Identifier: 00848782033065
• UDI-Public: (01)00848782033065(17)260926(10)BA27SSL
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 05/27/2022
• Report Date (Section F): 04/28/2022

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 Expiration Date: 09/26/2026
• Device Model Number: R497N
• Device Catalogue Number: R497N
• Device Lot Number: BA27SSL
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2022
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• 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