MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL MONOCRYL+; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B408
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 procedure on (b)(6) 2018 and barbed suture was used.During the procedure, the suture was not holding.The suture appears to not have any barbs on it.It is unknown how the procedure was completed.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
Product complaint # = > pc-000199791 date sent to the fda: 07/12/2018 the device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Investigation summary = > a needle-suture piece and one top foil were returned for evaluation.During the visual inspection of the opened sample, the swage and attachment area were as expected and a small suture piece still was attached to barrel needle.In addition, the end of the suture was cut appears to be by use of the surgical instrument and barbs could not be measured.No conclusion could be reached as to what may have caused the reported incident.Unopened samples were also returned for analysis.In 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 the needles were as expected.The suture was examined and the barbs were present along of the strand.Also, 10 barbs were randomly measured and all barbs met with the requirements.In addition, the loops were as expected.According to the condition of the samples, the barbs met the specification.

• Brand Name: STRATAFIX SPIRAL MONOCRYL+
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7614734
• Report Number: 2210968-2018-73554
• Device Sequence Number: 14008766
• Product Code: GAM
• UDI-Device Identifier: 10705031236356
• UDI-Public: 10705031236356
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 05/24/2018

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: 09/30/2019
• Device Catalogue Number: SXMP1B408
• Device Lot Number: LLH414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1