MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 4-0 S/A SH-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z310H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Events reported in medwatch report 2210968-2020-09980, 2210968-2020-09981, 2210968-2020-09982, 2210968-2020-09984, 2210968-2020-09985.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.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 unknown date and a suture was used.During the procedure, the suture pulled off the needle.These were not control release needles.Another like device was used to complete the procedure.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PDSII VIO 27IN 4-0 S/A SH-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: 11019061
• Report Number: 2210968-2020-09983
• Device Sequence Number: 3618086
• Product Code: NEW
• UDI-Device Identifier: 10705031060418
• UDI-Public: 10705031060418
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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: No Information
• Device Model Number: Z310H
• Device Catalogue Number: Z310H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1