MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SYMMETRIC PDS PLUS; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A408
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested and the following was obtained: when were the suture-needles noticed to detach (pre-op- before use on patient/dispensing/other? or intra-op- during use on patient while suturing?) ? no information.Confirm the needle(s) was/were retrieved after detachment during use on patient? yes, they were retrieved.If noticed with multiple procedures/patient events, confirm the total number of procedures/patient events? one.For each procedure/patient event please provide: event date, product code and lot number involved, procedure, event description, n/a.Was there any adverse patient outcome? no, there wasn't.If yes, was there any medical or surgical intervention performed? no, there wasn't.No further information will be provided.".
Event or Problem Description
It was reported that a patient underwent a neurosurgery procedure on (b)(6) 2018 and suture was used.During the procedure, the needle was detached from the suture.There were no adverse consequences to the patient.Additional information was requested.

• Brand Name: STRATAFIX SYMMETRIC PDS PLUS
• 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: 7679547
• Report Number: 2210968-2018-74265
• Device Sequence Number: 16486234
• Product Code: NEW
• UDI-Device Identifier: 10705031219335
• UDI-Public: 10705031219335
• 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): 06/15/2018

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 Catalogue Number: SXPP1A408
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/11/2018
• Patient Sequence Number: 1