MAUDE Adverse Event Report: ETHICON INC. PDS+ CLR 18IN 4-0 S/A P-3 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP494G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 procedure on (b)(6) 2018 and suture was used.During the procedure, the surgeon felt that the suture broke at a knot easily.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
Product complaint (b)(4), date sent to the fda: (b)(4).A dispensed needle-suture piece and one labeled winding former of product were returned for analysis.During the visual inspection of the needle/suture piece, the swage and attachment area was as expected and body fluids and several marks appear to be by use of a surgical instrument could be observed.The end suture was observed cut and the other section was not received for analysis.The product is an absorbable suture and as the sample was received open, the time of exposure that has the suture in the environment could not be determined.In addition, a functional test was performed and the tensile force were above the minimum requirements.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Due to the sample condition, the assignable cause of performance breakage suture, suggests an improper handling of the sample.

• Brand Name: PDS+ CLR 18IN 4-0 S/A P-3 PRM MP
• 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: 7449768
• Report Number: 2210968-2018-72221
• Device Sequence Number: 11052896
• Product Code: NEW
• UDI-Device Identifier: 10705031048416
• UDI-Public: 10705031048416
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• 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): 03/27/2018

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: PDP494G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 04/22/2018
• Supplement Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1