MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 5"(13CM) 9-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	2809G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts are being 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 an unknown procedure in 2018 and a suture was used.During surgery when the package was opened to prepare the suture, it was found that the suture was broken and scattered.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/22/2019.Device evaluation summary: an overwrap with a reparked needle and a suture of product code 2809, lot # lmh693 were returned for analysis.During the visual inspection of sample, the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined under magnification for suture remnant and it was observed that the remnant slightly protrudes from the needle hole.Marks on edge needle that appears to be by use of a surgical instrument were observed.The suture present elongation and the end suture was cut that appears to be by use of a surgical instrument.Marks were observed on the edge of the needle.In order to avoid this kind of damage the packages insert (ifu) cautions: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.According the sample condition, the assignable cause of performance breakage suture suggest an improper handling of the sample.

• Brand Name: ETHILON SUTURE 5"(13CM) 9-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7942872
• Report Number: 2210968-2018-76312
• Device Sequence Number: 16376307
• Product Code: GAR
• UDI-Device Identifier: 10705031003958
• UDI-Public: 10705031003958
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 09/10/2018

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: 10/31/2022
• Device Catalogue Number: 2809G
• Device Lot Number: LMH693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 01/22/2019
• Patient Sequence Number: 1