MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 3-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8558H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Not Applicable (3189)
Date of Event	03/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: *how the procedure was complete? needle was not identified as retained at the time of the (b)(6) 2019 surgery and surgery was closed.Was the needle retrieved from the patient? yes.Was there any adverse consequence associated with the patient? retained needle event.Please provide procedure name and date.Aortic valve replacement (b)(6) 2019.Please provide lot number.N/a - we do not have the packaging still.Investigation summary: it was reported pull off - suture needle.One needle of product code 8558h was received for analysis.During the visual inspection of the needle, the swage and attachment area were as expected and remnant of the suture was noted into the barrel hole and marks were observed on the edge of the needle that appears to be by the use of a surgical instrument.In addition, the suture was not returned for evaluation.The manufacturing records could not be reviewed as the batch number is unknown.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent aortic valve replacement on (b)(6) 2019 and suture was used.On (b)(6) 2020, during an unknown follow-up surgery, a retained needle pertaining to the (b)(6) 2019 procedure was found.It was reported that the needle was not identified as retained at the time of the initial procedure and the patient was closed.No additional information was provided.

• Brand Name: PRLNE BLU 36IN 3-0 D/A RB-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10434131
• Report Number: 2210968-2020-06261
• Device Sequence Number: 11231475
• Product Code: GAW
• UDI-Device Identifier: 10705031017092
• UDI-Public: 10705031017092
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2020

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 Model Number: 8558H
• Device Catalogue Number: 8558H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention