MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 27"(70CM) 2-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z317H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2019
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.
Event or Problem Description
It was reported that a patient underwent a metacarpal procedure on (b)(6) 2019 and suture was used.At the time of knotting and stretching the suture broke.It does not have the adequate strength.No adverse patient consequences were reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 07/23/2019.Device evaluation summary: it was received for analysis a needle suture piece of product code z317.During visual inspection of the needle-suture piece, the swage and attachment area were noted to be as expected, and the end of suture was observed cut appears to be by use of a surgical instrument.In addition, a functional test was performed on the sample and the tensile force met the requirements.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.Due to the sample condition, the assignable cause of performance breakage suture, was suggests an improper handling of the sample.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.

• Brand Name: PDS II SUTURE 27"(70CM) 2-0 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: 8674855
• Report Number: 2210968-2019-82465
• Device Sequence Number: 19297104
• Product Code: NEW
• UDI-Device Identifier: 10705031060494
• UDI-Public: 10705031060494
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: 09/30/2022
• Device Catalogue Number: Z317H
• Device Lot Number: LLM719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 76