MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 27"(70CM) 6-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP432H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 an unknown date and suture was used.The suture was broken during suturing.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
A manufacturing record evaluation was performed for the finished device mmz563 batch number, and no non-conformances were identified.Additional summary: it was received for analysis an unopened sample.During the visual inspection of the sample, no defects were found on the packages.The sample was opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were observed.A functional test was performed using an instron and the tensile strength force was above the minimum requirement.Per the condition of the representative sample, no performance - breakage suture was found and the tested samples met the finished goods requirements.

• Brand Name: PDS PLUS SUTURE 27"(70CM) 6-0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9245185
• Report Number: 2210968-2019-89126
• Device Sequence Number: 2549592
• Product Code: NEW
• UDI-Device Identifier: 10705031048287
• UDI-Public: 10705031048287
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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: 10/31/2020
• Device Catalogue Number: PDP432H
• Device Lot Number: MMZ563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/20/2019
• Patient Sequence Number: 1