MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 27"(70CM) 3-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP968H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.The actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: ml6566 and mmk086.A manufacturing record evaluation was performed for the finished device ml6566 number, and no non-conformances were identified.Expiration date: 09/30/2020.Date of mfg.: 10/16/2018.A manufacturing record evaluation was performed for the finished device mmk086 number, and no non-conformances were identified.Expiration date: 10/31/2020.Date of mfg.: 11/20/2018.
Event or Problem Description
It was reported that a patient underwent a spinal decompression surgery on (b)(6) 2019 and suture was used.The suture was broken at the 1st passing of the needle through the subcutis by continuous suturing.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 07/26/2019.H3 device evaluation summary: it was received for analysis two empty opened foils, a paper lid, a winding former with a suture piece partially dispensed and a needle suture piece of product code pdp968.During the visual inspection of the needle-suture piece, the swage and attachment area were noted to be as expected; however, the end of the suture pieces were cut that appears to be by use of a surgical instrument and the extremes did match between them.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition it was suggest an improper handling of the sample.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.

• Brand Name: PDS PLUS SUTURE 27"(70CM) 3-0 VIO
• 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: 8721003
• Report Number: 2210968-2019-83091
• Device Sequence Number: 16645205
• Product Code: NEW
• UDI-Device Identifier: 10705031048683
• UDI-Public: 10705031048683
• 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): 05/27/2019

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 Catalogue Number: PDP968H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1