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

Catalog Number SXPP1A406

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch mam983 mfg date: unk, exp date: unk batch lmz657 mfg date: unk, exp date: unk 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported that 4 total needle suture detachments occurred during 1 patient procedure with 2 reported lot numbers.How many detached from lot mam983? how many detached from lot lmz657?.

Event Description

It was reported that a patient underwent a laparotomy on (b)(6) 2018, and a barbed suture was used.During the procedure, the needle detached from the suture.There were no adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 01/17/2019.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested and the following was obtained: how many detached from lot mam983? 3 how many detached from lot lmz657? 1.Investigation summary: it was reported needle pull off.Four unopened samples of product code sxpp1a406, lot # mam983 and one sample of sxpp1a406, lot # lmk606 were returned for analysis.The issue sample was not received for analysis.During the visual inspection of four unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the samples received, no needle pull off was found, and the tested samples met the finished goods requirements.Attempts are being made to obtain the following information: it was reported that 3 needles detached from lot mam983 and 1 from lot lmz657.An additional lot # lmk606 was returned for evaluation.Is there a product complaint about this lot #? or was lot # lmk606 returned in error? to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

• Brand Name: SFX SYM PDS+ VIO 18IN 0 S/A CT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8196275
• MDR Text Key: 131410843
• Report Number: 2210968-2018-78022
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227675
• UDI-Public: 10705031227675
• Combination Product (y/n): N
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: SXPP1A406
• Device Lot Number: MAM983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Date Manufacturer Received: 01/08/2019
• Patient Sequence Number: 1