MAUDE Adverse Event Report: ETHICON INC. GUT PL FAG UD 18IN 6-0 S/A PC-1 PRM MP; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1916G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure it was reported that the suture was easily broken.It was unknown how the procedure was completed.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Representative samples: it was received for analysis eight unopened samples of product code 1916, lot mlu002.During the visual inspection of eight 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 performance - breakage suture was found and the tested samples met the finished goods requirements.Actual device: the actual device was received for evaluation.It was received for analysis an empty opened foil and a needle suture piece of product code 1916, lot mlu002.During the visual inspection of the needle-suture piece, the wage and attachment area of the needles were noted to be as expected.The suture was received broken (cut) appears to be by use of the surgical instrument.In addition, a functional test was performed and the tensile strength force was above the minimum requirement.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.Per the condition of the sample received, the assignable cause of the performance breakage suture was an improper handling.

• Brand Name: GUT PL FAG UD 18IN 6-0 S/A PC-1 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9332139
• Report Number: 2210968-2019-89985
• Device Sequence Number: 16705238
• Product Code: GAL
• UDI-Device Identifier: 10705031002920
• UDI-Public: 10705031002920
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: No Information
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 1916G
• Device Lot Number: MLU002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/13/2019
• Patient Sequence Number: 1