MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 5-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	K870H
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.Additional information was requested and the following was obtained: was the suture intentionally placed near the sterilization lamp? yes.Was the device inspected before its use after knowing that it may have been subjected to additional sterilization? the surgeon did not investigate the suture.The surgeon doubt the influence of sterilization lamp to the suture.The device means sterilization lamp or suture? please verify- was the suture that was exposed to additional sterilization broke during use on patent? yes.The suture was easily broken.How was case completed? yes.Another suture used for the patient.No further information will be provided.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 density and oral surgery procedure on an unknown date, and a suture was used.During surgery, the suture which was placed near a sterilizer lamp was broken during use.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/07/2018.Investigation summary: it was reported performance breakage suture.Two unopened samples were returned for analysis.During the visual inspection of the samples (a and b), yellow stain was observed on the corner of the packets, the samples were opened, and the swage and attachment area of needles were as expected.The sutures were dispensed without problems and examined along of the strand and it was noticed the unusual color in both sutures; the sutures were not black near to the needle.A functional test was performed and the tensile force were above the minimum requirements.An analytical characterization experiment, performed on black silk sutures, demonstrated that sutures lost their color within 48 hours if are exposed to a 3% hydrogen peroxide solution.Unopened suture product exposed to hydrogen peroxide vaporization decontamination (such as in an er) would eventually cause these black-colored sutures in current overwrap packaging to lose their black color, but it is not known how many decontamination treatments would be necessary to achieve this.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, no breakage suture was found on the sutures and the tested samples met the finished goods requirements.However, a color variation and foreign matter (yellow stain) were noted on the samples (a and b) caused by external cause.

• Brand Name: SILK SUTURE 30"(75CM) 5-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8061581
• Report Number: 2210968-2018-77054
• Device Sequence Number: 2745461
• Product Code: GAP
• UDI-Device Identifier: 10705031044548
• UDI-Public: 10705031044548
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/11/2018

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: 07/31/2019
• Device Catalogue Number: K870H
• Device Lot Number: HLE693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 01/07/2019
• Patient Sequence Number: 1