MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 6-0 S/A P-1 PRM; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z489G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2019
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.
Event or Problem Description
It was reported that the patient underwent an unknown plastic surgery procedure on (b)(6) 2019 and suture was used.The suture was broken during use.Another package was used with no problem.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Date sent to the fda: 02/07/2020.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

• Brand Name: PDSII CLR 18IN 6-0 S/A P-1 PRM
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9581766
• Report Number: 2210968-2020-00316
• Device Sequence Number: 14223006
• Product Code: NEW
• UDI-Device Identifier: 10705031061132
• UDI-Public: 10705031061132
• 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,Followup
• Report Date (Section B): 12/18/2019

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: 01/31/2024
• Device Model Number: Z489G
• Device Catalogue Number: Z489G
• Device Lot Number: PB5344
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 02/07/2020
• Patient Sequence Number: 1