MAUDE Adverse Event Report: ETHICON INC. PDS PLUS CLR 18IN 4-0 S/A PS-4 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP507G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 procedure on (b)(6) 2020; and suture was used.During the procedure, the suture broke during suturing.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: PDS PLUS CLR 18IN 4-0 S/A PS-4 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10778026
• Report Number: 2210968-2020-08597
• Device Sequence Number: 1047906
• Product Code: NEW
• UDI-Device Identifier: 10705031048478
• UDI-Public: 10705031048478
• 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
• Report Date (Section B): 10/22/2020

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 Model Number: PDP507G
• Device Catalogue Number: PDP507G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1