MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL PDS+; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1B421
Medical Device Problem Codes	Break (1069); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation: a labeled winding former and a dispensed needle-suture of product were returned for analysis.During the visual inspection of the sample, the swage and attachment area were as expected; however slight marks on the body of needle that appear to be by use of surgical instrument were noted.The suture was examined, the barbs and loops were present in the strand; but damage along the suture and a knot in the middle were observed.The barbs could not be measured.A functional test was performed using and the tensile force was above the minimum requirements.The dhr review could not be conducted, because the batch number of the complaint is unknown.Per the sample condition, an assignable cause could not be determined.
Event or Problem Description
It was reported that a patient underwent an unknown wound closure procedure in 2018 and a suture was used.During surgery, when the surgeon put his fingers on either side of the incision and applied a little pressure, the tissue fell apart and the suture broke.It was noticed that there were no barbs intermittently along the suture.The procedure was completed by using a replacement.There were no patient consequences.

• Brand Name: STRATAFIX SPIRAL PDS+
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8050582
• Report Number: 2210968-2018-77036
• Device Sequence Number: 1484568
• Product Code: NEW
• UDI-Device Identifier: 10705031235922
• UDI-Public: 10705031235922
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2018

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: No Information
• Device Catalogue Number: SXPP1B421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2018
• Initial Report FDA Received Date: 11/08/2018
• Patient Sequence Number: 1