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

Catalog Number	PDPB340
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.
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 when holding the needle by needle-holder.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/14/2019.Investigation summary: it was reported performance pull off suture needle.A labeled winding former with a suture and a detached needle of product code pdpb340 were returned for analysis.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.The suture was examined and the other suture end is severely cut (damaged), resulting in a clip off defect.This condition caused the needle pull.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Per the sample condition the assignable cause of the performance - pull off suture needle pre-op suggest a clip off defect.This defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.

• Brand Name: PDS PLUS SUTURE 27"(70CM) 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: 8150848
• Report Number: 2210968-2018-77664
• Device Sequence Number: 2279683
• Product Code: NEW
• UDI-Device Identifier: 10705031048799
• UDI-Public: 10705031048799
• 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): 11/19/2018

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: PDPB340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 01/14/2019
• Patient Sequence Number: 1