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

Catalog Number	SXMP1B106
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
(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 procedure on an unknown date and suture was used.Dr was busy closing skin when suture snap.He used another suture.No adverse patient consequences were reported.No additional information has been provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/30/2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Evaluation: an empty opened foil and a dispensed needle-suture of product were returned for analysis.During the visual inspection of sample, the swage and attachment area of needle were as expected.The suture was examined and present body fluids along strand and the first loop appeared to be cut by the use of a surgical instrument.The product contains an absorbable suture and as the sample was received open, the time of exposure that has the suture in the environment could not be determined.In addition, a functional test was performed on the sample and the tensile 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 sample condition of the received needle-suture, the assignable cause of the suture breakage suggest an improper handling of the sample.

• 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: 7949199
• Report Number: 2210968-2018-76425
• Device Sequence Number: 19067718
• Product Code: GAM
• UDI-Device Identifier: 10705031236684
• UDI-Public: 10705031236684
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

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: 12/31/2018
• Device Catalogue Number: SXMP1B106
• Device Lot Number: LAH372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 12/01/2018
• Patient Sequence Number: 1