MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 3-0 S/A RB-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP305H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
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.Additional information was requested and the following information was obtained: was the needle removed from the patient during the same procedure? no further information is available.Was there any patient consequence or injury? there were no adverse consequences to the patient.What was used to complete the procedure? no further information is available.Procedure name? no further information is available.Lot number? no further information is available.Are samples being returned for evaluation? no sample will be returned.No further information will be provided.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on (b)(6) 2020 and a suture was used.During the procedure, the suture was detached from the needle during use.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Date sent to the fda: 07/27/2020 additional information: d8, e2 additional information was requested, and the following was obtained: was the needle removed from the patient during the same procedure? =>no further information is available.Was there any patient consequence or injury? =>there were no adverse consequences to the patient.What was used to complete the procedure? =>no further information is available.Procedure name? =>no further information is available.Lot number? =>no further information is available.Are samples being returned for evaluation? =>no sample will be returned.No further information will be provided.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PDS+ VIO 27IN 3-0 S/A RB-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10304700
• Report Number: 2210968-2020-05437
• Device Sequence Number: 2864381
• Product Code: NEW
• UDI-Device Identifier: 10705031047983
• UDI-Public: 10705031047983
• 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): 07/08/2020

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: PDP305H
• Device Catalogue Number: PDP305H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1