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

Catalog Number	802H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.
Event or Problem Description
It was reported that a patient underwent an open hysterectomy on (b)(6) 2018 and suture was used.During the procedure, the suture strand broke along multiple points when given little pressure.A different device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.Empty, opened overwrap packets and a needle-suture tangle on the empty opened foil of product were returned for analysis.During the visual inspection of unused sample, the swage and attachment area were as expected.The suture was dispensed without problems and examined along the strand with no defects, damage or suture breakage observed.A functional test was performed and the tensile force was 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 unused sample, no breakage of suture was found.

• Brand Name: GUT CHR UD 27IN 0 S/A CT
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7841627
• Report Number: 2210968-2018-75587
• Device Sequence Number: 1980824
• Product Code: GAL
• UDI-Device Identifier: 10705031012288
• UDI-Public: 10705031012288
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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: 05/31/2022
• Device Catalogue Number: 802H
• Device Lot Number: LGM577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/19/2018
• Patient Sequence Number: 1