MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT; :POLYSYN 3-0 UNDYED 1X18" PS-2

Model Number G497N

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Lot aahe541 and lot aahb006 manufactured 12/30/2020, expires 12/29/2025, udi code were used for the procedure.The review of the device history records confirmed the finished goods and components met all requirements throughout the incoming inspection, manufacturing, in-process and final inspection processes.No sterile samples were returned for testing/review.No retained samples were available for review.No photos of the surgical site(s), patient's incisions were provided for review.If samples and/or photos become available, the samples will be tested, photos will be reviewed and the results will be documented in the file.A follow-up report will be submitted at that time.The "precautions" section of the ifu states, "infections, erythema, foreign body reactions, spitting 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 polysyn¿ (polyglycolic acid) suture".The ¿adverse reactions¿ section of the ifu for the pga devices states, ¿adverse effects associated with the use of this device may include, wound dehiscence, failure to provide adequate wound support in closure of the site where expansion, stretching or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from condition which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs and transitory local infection at the wound site¿.The "actions" section of the ifu for this material states, "poly"syn¿ (polyglycolic acid) suture elicits a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue.Progressive loss of tensile strength and eventual absorption of polysyn¿ (polyglycolic acid) synthetic absorbable sutures occurs by hydrolysis, where the polymer degrades to glycolic acid which is subsequently absorbed and metabolized by the body.Absorption begins as a loss of tensile strength without appreciable loss of mass.Implantation studies in animals indicate that polysyn¿ (polyglycolic acid) suture retains at least 50% of its original tensile strength at two weeks post implantation, with approximately 20% remaining at three weeks.Absorption of polysyn¿ (polyglycolic acid) synthetic absorbable suture is essentially complete between 50 and 90 days.Without receiving photos of the incisions/surgical site, details of the procedures performed, post-operative instructions and/or events that may have occurred resulting in the wound healing difficulties, placement of the devices or the surgeon's technique, a definitive root cause cannot be determined at this time.

Event Description

The patient had a severe case of spitting of her sutures bilaterally on her vertical breast incisions as well as on parts on her abdomen (she had a mastopexy with a removal and placement of implants along with an abdominoplasty).She required extensive wound care post op and her incision took over 5 weeks to completely heal.Dr (b)(6) has not experienced anything to this degree before during his time in practice with has been over 20 years.

Manufacturer Narrative

Sterile samples from the reported lot were returned for visual review and testing.No defects or abnormalities were observed on the packages or devices.The devices met the current specification including the usp tensile strength requirements for 3-0 pga material.No other complaints were received from any other customers/distributors for the lots reported.

• Brand Name: SHARPOINT
• Type of Device: :POLYSYN 3-0 UNDYED 1X18" PS-2
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: eliot knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 11980232
• MDR Text Key: 255598756
• Report Number: 3010692967-2021-00022
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10848782015082
• UDI-Public: (01)10848782015082(17)251227(10)AAHE541
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K965162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/13/2021,06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G497N
• Device Lot Number: AAHE541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 05/13/2021
• Date Manufacturer Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female