MAUDE Adverse Event Report: ETHICON INC. PDSII UD 18IN 6-0 S/A PS-6 PRM MP; SUTURES - ABSORBABLE

Catalog Number	Z510G
Medical Device Problem Codes	Material Frayed (1262); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The following information was requested, but unavailable: could you please confirm if the suture was frayed or if the suture present any issue related with the surface? please explain.Could you please provide lot number? what was used to complete the procedure? no further information will be provided.Attempts are being made to retrieve the device.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.(b)(4).
Event or Problem Description
It was reported that a patient underwent a ptosis procedure on an unknown date and suture was used.The suture was reported to be torn/frayed/curled during use on the dermis.There were no adverse consequences to the patient.No further information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: (b)(4).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 information: d9, h6.Additional h3 investigation summary: an empty winding former, a paper lid and a needle/suture partially dispensed product code z510 were received to ethicon inc for evaluation.As per visual inspection of the sample received for evaluation, the swage and attachment area were noted to be as expected, but an additional suture was attached to needle (two sutures instead of one).In addition, the strands were noted with damages and fraying.The wrong number of sutures attached to needle and damaged suture defects have been correlated to the manufacturing process.The manufacturing records couldn't be reviewed as the batch number is unknown.Based on the information currently available, the wrong number of sutures attached to needle and damaged suture were identified during the visual inspection of the video received.

• Brand Name: PDSII UD 18IN 6-0 S/A PS-6 PRM MP
• Common Device Name: SUTURES - ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12069791
• Report Number: 2210968-2021-05827
• Device Sequence Number: 4094214
• Product Code: NEW
• UDI-Device Identifier: 10705031061330
• UDI-Public: 10705031061330
• 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,Followup
• Report Date (Section B): 06/02/2021

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 Catalogue Number: Z510G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/03/2021
• Patient Sequence Number: 1