MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y494G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported that the device had a pull off - suture needle issue.Three unopened samples of product code y494, lot mmm068 were returned for analysis.The complaint sample was not received for evaluation.During the visual inspection of three 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 strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was there only 1 needle that fell off the suture? if more than 1, please provide the total quantity.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle fell off the suture.No patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint (b)(4).Additional information was requested and the following was obtained: was there only 1 needle that fell off the suture? if more than 1, please provide the total quantity.: 9 were affected.Representative samples returned to support investigation of 9 device issues captured in reports 2210968-2019-86886, 2210968-2019-86887, 2210968-2019-86890, 2210968-2019-86891, 2210968-2019-86892, 2210968-2019-86894, 2210968-2019-86895 and 2210968-2019-86902.Analysis results have been included in mw reports for each.

• Brand Name: MCRYL UD 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8884838
• Report Number: 2210968-2019-85433
• Device Sequence Number: 11445809
• Product Code: GAN
• UDI-Device Identifier: 10705031059337
• UDI-Public: 10705031059337
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 10/31/2023
• Device Catalogue Number: Y494G
• Device Lot Number: MMM068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/10/2019
• Patient Sequence Number: 1