MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 12IN 4-0 S/A M-2; SUTURE, ABSORBABLE, NATURAL

Catalog Number	752G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot laz619, and no non-conformances were identified.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.The photo upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used on a skin lesion.During the procedure, after passing through the patients skin approximately three times, the needle broke.The doctor was able to extract both ends of the needle and no impact on patient.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 01/15/2020.Additional h-3 summary: an open box with eleven unopened samples were received for evaluation.The complaint sample was not received for evaluation.During the visual inspection, no defects were found on the packages.The swage and attachment area were noted to be as expected.No needles breakage were observed.The sutures were examined along of the strands and no defects were observed.Also, the samples were tested by resistance test to needle and met the requirements.Per the conditions of the samples received, no performance breakage needle were found.Two pictures were returned for analysis.Upon visual inspection of the pictures, a broken needle could be observed, and no conclusion could be reach on how this happen as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

• Brand Name: GUT CHR UD 12IN 4-0 S/A M-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: 9473344
• Report Number: 2210968-2019-90935
• Device Sequence Number: 2593078
• Product Code: GAL
• UDI-Device Identifier: 10705031009912
• UDI-Public: 10705031009912
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K946173
• 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): 11/25/2019

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: 12/31/2021
• Device Catalogue Number: 752G
• Device Lot Number: LAZ619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/15/2020
• Patient Sequence Number: 1