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

Catalog Number	SXPP1A200
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc-(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Investigation summary: it was reported performance pull off suture needle pre-op.An empty opened folder, an empty labeled winding former, a dispensed suture and a detached needle were returned for analysis.During the visual inspection of the needle the swage and attachment area were as expected.The barrel hole of the needle was examined under 20x magnification and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement.  the manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, the assignable cause of the performance pull off suture needle pre-op is a short insertion.
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, the suture was detached from the needle when holding the needle with a needle holder.It was not used for the patient.There were no adverse patient consequences reported.Upon evaluation, the insertion did not meet the requirement.No additional information was provided.

• Brand Name: SFX SYM PDS+ 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 0151
• MDR Report Key: 8108203
• Report Number: 2210968-2018-77360
• Device Sequence Number: 19350383
• 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
• Report Date (Section B): 10/30/2018

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: 10/31/2019
• Device Catalogue Number: SXPP1A200
• Device Lot Number: LMK296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/27/2018
• Patient Sequence Number: 1