MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 18IN 7-0 D/A CS175-8; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1745G
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).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The product 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.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.Please explain, what do you mean by "sutures are popping out "? were the sutures detaching from needles? when was it noticed the popping off/detachment of needle-suture? pre-op- before use on patient- while in package noticed upon opening? or during dispensing/during preparation at or table? or intra-op- during use on patient- while suturing / tying knots? kindly confirm the total qty involved (eaches or box ) with suture -needle detachment during single event report/single procedure? was this noticed with single or multiple patient events/procedures? if multiple, please confirm the specific number of patient events /procedures? have any of these events been previously reported to ethicon? if yes, please provide complaint file number/ affiliate number? for each patient event please provide additional complaint details: event date, product code and lot number involved, procedure, event description, was there any adverse patient outcome? if yes, was there any medical or surgical intervention performed, was procedure completed successfully and how?, any sample return.Etc? 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.Did 18 needles detach from the suture during this procedure?.
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, after the needle passed through the tissue, the surgeon pulled the ¿thread¿ through the tissue and the needle easily detached from the suture strand.There were no adverse patient consequences reported.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Additional information: 8/17/2018 additional evaluation summary: representative samples were returned for evaluation.During the visual inspection of the unopened samples, no defects were found on the packages.The samples were opened and the swage and attachment area of needles were as expected.The sutures were examined along strand and no defects, damage or needle pull could be observed.A functional test was performed on the samples using a instron and the pull force met the 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 representative samples received, no performance - pull off suture needle were found.

• Brand Name: GUT CHR UD 18IN 7-0 D/A CS175-8
• 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: 7823635
• Report Number: 2210968-2018-75474
• Device Sequence Number: 1116904
• Product Code: GAL
• UDI-Device Identifier: 10705031002340
• UDI-Public: 10705031002340
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/01/2018

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: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 1745G
• Device Lot Number: LLJ546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 10/01/2018
• Patient Sequence Number: 1