MAUDE Adverse Event Report: ETHICON INC. PDSII SUT 18IN(45CM) 4-0 CLR; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z507G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc-(b)(4).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.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2018 and suture was used.During the procedure, the suture was detached from the needle.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/27/2018.Evaluation: a labeled winding former, a dispensed suture and a detached needle of product were returned for analysis.During the visual inspection of detached needle, the swage and attachment area were as expected; however, the barrel hole of the needle was observed to have damage (crushed) and marks on the edge needle that appear to be by use of a surgical instrument.The end of the suture was found to be cut and damaged.This condition caused the needle to be separated from the suture.The dhr review could not be conducted, because the batch number of the complaint is unknown.Per the condition of the sample received, the assignable cause of the suture needle pull off is improper handling.

• Brand Name: PDSII SUT 18IN(45CM) 4-0 CLR
• 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: 8015140
• Report Number: 2210968-2018-76811
• Device Sequence Number: 19147938
• Product Code: NEW
• UDI-Device Identifier: 10705031061293
• UDI-Public: 10705031061293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• 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): 10/01/2018

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 Catalogue Number: Z507G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 11/27/2018
• Patient Sequence Number: 1