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

Model Number	Z507G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint: (b)(4).Component code: (b)(4) device not returned.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.Additional information was requested, and the following was obtained: what was being done when the suture broke (removal from package / during passage through tissue/ during tying)? the issue was found during passage through tissue.The following information was requested, but unavailable: what tissue was being approximated or sutured when it broke? procedure name and date? event date? 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 the patient underwent an unknown surgery on unknown date and the suture was used.During surgery, when putting the first stitch, it was found that a part of the suture had been torn, so use was stopped.It is unknown whether the suture had been torn when opening the package.There were no patient consequences reported.

• Brand Name: PDSII CLR 18IN 4-0 S/A PS-4 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11668785
• Report Number: 2210968-2021-03385
• Device Sequence Number: 3496461
• Product Code: NEW
• UDI-Device Identifier: 10705031061293
• UDI-Public: 10705031061293
• 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): 03/18/2021

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: Z507G
• Device Catalogue Number: Z507G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/14/2021
• Patient Sequence Number: 1