MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 60"(150CM) 2 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D7190
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: customer states that he has had issues with this particular suture on several occasions.Can you please confirm how many times/patient events? -unknown were they previously reported? yes.How was the procedure completed? used a different product what was the event date? (b)(6) 2018.What was the name of the procedure? unknown.Was there any medical/surgical intervention and/or treatment rendered? no.
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date and suture was used.During use, going to tie a knot, the suture shredded.Suture removed from tissue.Then the suture prematurely separated from needle at swage.There were no patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: it was reported - needle pull off and suture breakage.A top foil and a dispensed suture of product code d7190, lot mgz197 were returned for analysis.The needle was not returned for evaluation.During the visual inspection of the sample, the suture has begun with the process of disintegration; this is the cause that the needle was detached from the suture and the broken suture.In addition, the top foil was examined and no damage or defects were observed on the packet.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause of needle pull off and suture breakage is suture degradation; however, it could not be determined what may have caused the disintegration of the suture.

• Brand Name: PDS II SUTURE 60"(150CM) 2 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: 8228572
• Report Number: 2210968-2019-78279
• Device Sequence Number: 2027054
• Product Code: NEW
• UDI-Device Identifier: 10705031027350
• UDI-Public: 10705031027350
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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 Expiration Date: 05/31/2023
• Device Catalogue Number: D7190
• Device Lot Number: MGZ197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 01/31/2019
• Patient Sequence Number: 1