MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 2-0 S/A CT-2; SUTURE, ABSORBABLE, NATURAL

Catalog Number	883H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pdm349 batch number, and no non-conformances were identified.Additional information was requested and the following was obtained: please explain what part of the device broke; needle or suture thread? or other issue? the suture itself broke.Multiple ligatures were attempted with the same result.New needle holders were also used to insure that it was not an equipment problem.How was case completed? another type of suture was used to complete the surgery -pds.Is the actual and/or unused sterile samples still available to return for evaluation? the affected suture was discarded however the remainder of the box is available.
Event or Problem Description
It was reported by a veterinarian that an animal underwent an unknown procedure on (b)(6) 2019 and suture was used.The suture broke while knot tying during surgery.Another type of suture was used to complete the surgery.
Additional Manufacturer Narrative
(b)(4).Additional investigation summary: one opened box with unopened samples of product code 883, lot pdm349 was received for analysis.The complaint sample was not received for evaluation.During the visual inspection samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were observed.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no breakage suture was found and the tested samples met the finished goods requirements.

• Brand Name: GUT CHR UD 27IN 2-0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9322724
• Report Number: 2210968-2019-89920
• Device Sequence Number: 14011502
• Product Code: GAL
• UDI-Device Identifier: 10705031021105
• UDI-Public: 10705031021105
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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: 03/31/2024
• Device Catalogue Number: 883H
• Device Lot Number: PDM349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/10/2019
• Patient Sequence Number: 1