MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ VIO 18IN 3-0 S/A PS-1 PRM; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2018 and a suture was used.During surgery, the suture broke during surgery.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: SFX SYM PDS+ VIO 18IN 3-0 S/A PS-1 PRM
• 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: 8060505
• Report Number: 2210968-2018-77053
• Device Sequence Number: 11310156
• Product Code: NEW
• UDI-Device Identifier: 10705031227736
• UDI-Public: 10705031227736
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 10/15/2018

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: SXPP1A100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/12/2018
• Patient Sequence Number: 1