MAUDE Adverse Event Report: ETHICON, LLC PDS; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	PDP880G
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Middle aged female with history of pelvic pain, vaginal bleeding and fibroids.Presented to operating room for scheduled abdominal hysterectomy, bilateral salpingo-oophorectomy and cystoscopy.Upon completion of the surgery and closing the incision, the tip of the 1 pds looped suture broke off in the patient.The tip was not located.Wound was irrigated, no xray taken.No known harm to patient.Broken device was not saved.Pictures are representation of what was used.

• Brand Name: PDS
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON, LLC; 475 c street; los frailes industrial park, suite 401; guaynabo PR 00969
• MDR Report Key: 10777947
• Report Number: 10777947
• Device Sequence Number: 3645823
• Product Code: NEW
• UDI-Device Identifier: 30705031048663
• UDI-Public: (01)30705031048663(17)211231(10)QAMHSC
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/22/2020
• Report Date (Section F): 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PDP880G
• Device Catalogue Number: PDP880G
• Device Lot Number: QAMHSC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2020
• Patient Sequence Number: 1
• Patient Weight: 53
• Date Report Sent to FDA: 10/22/2020