MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 5-0 S/A P-2 PRM; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z503G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being made to receive a device for evaluation.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: it was reported:""during an unknown surgery, sutures broke"" please clarify: how many suture broke during the procedure? the sales rep reported 8 devices.What was used to complete the procedure? no further information is available.What tissue was being approximated or sutured when it broke? no further information is available.What is the name and date of the procedure? no further information is available.What is the event date? no further information is available.Device return status/follow up? we regularly contact with sales rep about the device returning.No further information will be provided.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted, 2210968-2020-05319, 2210968-2020-05320, 2210968-2020-05322, 2210968-2020-05323, 2210968-2020-05324, 2210968-2020-05325 and 2210968-2020-05327.
Event or Problem Description
It was reported that the patient underwent an unknown surgery on unknown date and the suture was used.During the surgery, the suture broke.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 07/28/2020.Additional information: h4, h6.A manufacturing record evaluation was performed for the finished device lot number qbmjad, and no non-conformances were identified.Additional information was requested, and the following was obtained: qty of product involved: 8 = 1.Qty to be returned: 8 = 3.Corrected information: initially 8 devices were reported in this event.Additional information was received that only 1 device was involved in this event.This event will be captured in mw report # 2210968-2020-05318 only.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 08/24/2020.Additional information: h6.Additional h3 investigation summary: one open box with two unopened samples of product code z503g, lot qbmjad was received for analysis.The complaint sample was not returned for evaluation.During the visual inspection of two samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged or suture breakage were observed.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PDSII CLR 18IN 5-0 S/A P-2 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: 10278777
• Report Number: 2210968-2020-05318
• Device Sequence Number: 19391796
• Product Code: NEW
• UDI-Device Identifier: 10705031061262
• UDI-Public: 10705031061262
• 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,Followup
• Report Date (Section B): 07/01/2020

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: 01/31/2025
• Device Model Number: Z503G
• Device Catalogue Number: Z503G
• Device Lot Number: QBMJAD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/15/2020; 08/07/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 07/28/2020; 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1