MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 6-0 S/A TF; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z432H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint#: (b)(4).The following information was requested, but unavailable: was the needle piece removed from the patient during the same procedure? procedure name and date? lot number? event date? to date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on unknown date and the suture was used.It was also reported that the needle was detached from the suture immediately during use.There were no adverse consequences to the patient.No further information is available.

• Brand Name: PDSII VIO 27IN 6-0 S/A TF
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10418317
• Report Number: 2210968-2020-06165
• Device Sequence Number: 3094668
• Product Code: NEW
• UDI-Device Identifier: 10705031060937
• UDI-Public: 10705031060937
• 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
• Report Date (Section B): 08/10/2020

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: Z432H
• Device Catalogue Number: Z432H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1