MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 3-0 S/A PC-25 PRM; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	W538G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent a open reduction and internal fixation (orif) on an unknown date in 2023 and suture was used.Experienced the suture detachment from swage.Another suture was opened up and was okay.No reported adverse patient consequences.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: was surgery delayed due to the reported event? unknown, was procedure successfully completed? unknown, were fragments generated? unknown, if yes, were they removed easily without additional intervention? unknown, patient status/ outcome / consequences no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown, additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Please confirm the number of devices in which "suture detachment was observed"? event descriptions mention 2 devices, however quantity of product involved was entered as 8.2 was detached during the surgery but total 8 unused pieces remaining when did the needle detach/pull off from the suture (in the package, during removal from the package, during handling before use on patient or during use on the patient)? please specify.The detachment happened during handling during use on the patient.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Note: events reported via: mw# 2210968-2023-07646.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, or its employees that the report constitutes an admission that the product, ethicon, 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: PRLNE BLU 18IN 3-0 S/A PC-25 PRM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17914834
• Report Number: 2210968-2023-07645
• Device Sequence Number: 6627304
• Product Code: GAW
• UDI-Device Identifier: 10705031238282
• UDI-Public: 10705031238282
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

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: W538G
• Device Lot Number: TBBHUA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown