MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 5-0 S/A PC-3 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z844G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported "the doctor passed the stitch and the moment of knotting the needle is broken" please clarify.Was the needle retrieved during the same procedure? what is current condition of the patient? procedure date? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a septorhinoplasty on (b)(6) 2020 and suture was used.During the procedure, the doctor passed the stitch and the moment of knotting the needle is broken.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PDSII CLR 18IN 5-0 S/A PC-3 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: 10392905
• Report Number: 2210968-2020-06012
• Device Sequence Number: 3155815
• Product Code: NEW
• UDI-Device Identifier: 10705031061842
• UDI-Public: 10705031061842
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2020

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 Expiration Date: 07/31/2024
• Device Model Number: Z844G
• Device Catalogue Number: Z844G
• Device Lot Number: PJU067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/11/2020
• Patient Sequence Number: 1
• Patient Age: 32 YR