MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 2-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8623H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent a low anterior resection on (b)(6) 2020 and suture was used.During the procedure, the suture was broken while performing the suturing.Another suture was used.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint: (b)(4).Date sent to the fda: 04/06/2020.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Attempts are being made to receive a device for evaluation.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

• Brand Name: PROLENE SUTURE 30"(75CM) 2-0 BLU
• 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: 9688470
• Report Number: 2210968-2020-01058
• Device Sequence Number: 17057494
• Product Code: GAW
• UDI-Device Identifier: 10705031017962
• UDI-Public: 10705031017962
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2020

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 Expiration Date: 05/31/2023
• Device Model Number: 8623H
• Device Catalogue Number: 8623H
• Device Lot Number: AK8231
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 04/06/2020
• Patient Sequence Number: 1