MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 0 S/A OS-6; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A200
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).A manufacturing record evaluation was performed for the finished device lot lmz412, and no non-conformance were identified.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 surgery on an unknown date and a barbed suture was used.During the procedure, the suture was torn during use.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).One empty opened foil, an empty labeled winding former and a needle-suture piece of product code sxpp1a200, lot lmz412 were returned for analysis.During the visual inspection of the needle/suture piece, the swage and attachment area were noted to be as expected.However, marks on the body needle and the end cut that appears to be by the use of a surgical instrument could be observed.Also, suture piece was fraying and damaged.The other section of the suture was not returned for analysis and due to the condition of the sample the functional test can¿t be performed.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.A manufacturing record evaluation was performed for the finished device lmz412 number, and no non-conformances were identified.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 0 S/A OS-6
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9395137
• Report Number: 2210968-2019-90369
• Device Sequence Number: 11251246
• Product Code: NEW
• UDI-Device Identifier: 10705031227668
• UDI-Public: 10705031227668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113004
• 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
• Report Date (Section B): 11/12/2019

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: 10/31/2019
• Device Catalogue Number: SXPP1A200
• Device Lot Number: LMZ412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/31/2019
• Patient Sequence Number: 1