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).A manufacturing record evaluation was performed for the finished device pgz457 batch number, and no non-conformances were identified.Attempts are being 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 the patient underwent an unknown surgery on an unknown date and suture was used.The suture broke during surgery.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Date sent to the fda: (b)(6) 2019 the product code pdp432 contains 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 and no additional test could be performed.
Additional Manufacturer Narrative
One empty labeled winding former and a needle-suture combination in three sections of product code pdp432, lot pgz457 were received for analysis.During the visual inspection of the needle/suture piece, the swage and attachment area were noted to be as expected.However, marks on the body needle and the end of the suture cut that appears to be by the use of a surgical instrument could be observed.The other two sections of the suture were examined, damaged on the suture pieces were noted and the ends were cut.Due to the condition of the sample the functional test cannot be performed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling.

• 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: 9246634
• Report Number: 2210968-2019-89105
• Device Sequence Number: 3935275
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2019

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: 05/31/2021
• Device Catalogue Number: PDP432H
• Device Lot Number: PGZ457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/15/2019; 11/15/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/04/2019; 12/05/2019
• Patient Sequence Number: 1