MAUDE Adverse Event Report: ETHICON INC. SFX SPI MCRYL+ UNI 27IN 3-0 SA PS PRM MP; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Model Number	SXMP1B113
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 unknown knee procedure on (b)(6) 2020 and a barbed suture was used.During the procedure, the suture snapped with very minimal force applied about half way through closing skin of a knee.The surgeon used another of the same suture, but started at the opposite apex of the wound.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 4/30/2020.A manufacturing record evaluation was performed for the finished device batch pcj906, sxmp1b11307 and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/28/2020.Additional h3 investigation summary: one open winding former with a needle-suture in several sections of product code sxmp1b113, lot pcj906 were received for analysis.During visual inspection of the needle-suture piece, the swage and attachment area were noted to be as expected; however, marks appears to be by use of surgical instrument could be on the body needle.The suture pieces were examined, and they have begun with degradation process and due this condition no functional test could be performed.In addition, the foil was not returned for evaluation.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as on what caused the suture snapped with very minimal force applied.One unopened sample of product code sxmp1b113, lot pcj906 was received for analysis.During the visual inspection of the sample, no defects were found on the package.The sample was opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were observed.A functional test was performed and the tensile strength force was above the minimum requirement.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.The devices performed without any difficulties noted.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SFX SPI MCRYL+ UNI 27IN 3-0 SA PS PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9787266
• Report Number: 2210968-2020-01730
• Device Sequence Number: 16283505
• Product Code: GAM
• UDI-Device Identifier: 10705031236721
• UDI-Public: 10705031236721
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N12159
• 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,Followup
• Report Date (Section B): 02/06/2020

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: 02/28/2021
• Device Model Number: SXMP1B113
• Device Catalogue Number: SXMP1B113
• Device Lot Number: PCJ906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 04/29/2020; 10/16/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/30/2020; 10/28/2020
• Patient Sequence Number: 1