MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO LL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	SP-5682
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Pain (1994); Tissue Damage (2104); Injury (2348); Impaired Healing (2378); Post Operative Wound Infection (2446); Ambulation or Postural Difficulties (2544); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post operatively, on a surgical repair of a ruptured anterior tibialis, the patient, sustained a disruption of traumatic injury wound repair due to dissolvable sutures that failed to dissolve leading to an infection.The patient required numerous out patient visits with wound therapy department due to the stitches failing to absorb.When wound care explored the wound to determine the depth, they located these sutures were still in the wound bed, undissolved.The patient had to have a peripherally inserted central catheter line (picc) placed and given intravenous vancomycin as outpatient and then transitioned to oral clindamycin.The patient had to have a wound vacuum assisted closure (vac) placed as well to help manage drainage from this site.The patient was on oral and intravenous antibiotics for several months and required advanced wound dressings, as well as, periodic conservative sharp debridement.The surgical wound dehisced, exposing the anterior tibialis tendon and surrounding soft tissue.Impairment included loss of ankle mobility and strength.The soft tissue covering the surface of the foot and anterior ankle was relatively thin particularly in an individual with normal body fat which was the case with the patient.Loss of ankle motion and strength results in an abnormal gait which stresses the structures of the knee, hip and back.The latter particularly pertains to the wrist and shoulder when an individual brace for a fall.During treatment the patient was taking pain.The patient underwent surgical debridement four weeks post tendon repair.The original surgery was on (b)(6) 2019 and the second was on (b)(6) 2019.The infection resolved and once the wound was healed, the patient was discharged between (b)(6) to (b)(6) 2020.The patient was also treated with assistance from an infections diseases medical doctor via tele medicine.

• Brand Name: SURGIPRO LL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 10032831
• Report Number: 9612501-2020-00707
• Device Sequence Number: 19572325
• Product Code: GAW
• UDI-Device Identifier: 10884521036871
• UDI-Public: 10884521036871
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/07/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2013
• Device Model Number: SP-5682
• Device Catalogue Number: SP-5682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention