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

Catalog Number	SXPP1B417
Medical Device Problem Code	Break (1069)
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
(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 a total knee arthroplasty on (b)(6) 2018 and a barbed suture was used.During the procedure, while suturing deep dermis tissue, in a continuous barb closure, the needle broke, three quarters of the way up the needle from the suture strand.The needle tip was retrieved and saved, along with the remaining needle and suture.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Additional Manufacturer Narrative
Pc-000201810 date sent to the fda: 08/13/2018 additional information: additional summary: a failed suture needle was returned for evaluation.Upon evaluation, a fracture was observed in the body of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage, a cup-and-cone shaped fracture and macroscopic plastic deformation observed coincidental to the fracture provide additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred from mechanical deformation, indents and scratches, due to gripping, bending and overstressing of the needle.  there is no evidence of any material flaw that would cause premature failure.

• 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: 7619797
• Report Number: 2210968-2018-73586
• Device Sequence Number: 1590291
• Product Code: NEW
• UDI-Device Identifier: 10705031236172
• UDI-Public: 10705031236172
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K150670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2018

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: 09/30/2018
• Device Catalogue Number: SXPP1B417
• Device Lot Number: KLJ318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 06/20/2018; 07/19/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 07/12/2018; 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1