MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 6-0 D/A CC175-8 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	W8807
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2022 and suture was used.During the procedure, the suture broke.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Component code: (b)(4).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.What tissue was being approximated or sutured when it broke? what was used to complete the procedure? lot number? procedure name and date? event date? device return status/follow up?.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/13/2022.H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803.Part 4 subpart b.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.The following information was requested, but was unavailable: "reply from affiliate: what tissue was being approximated or sutured when it broke? unknown.What was used to complete the procedure? unknown.Lot number? unknown.Procedure name and date? cvs.Date: unknown.Event date? unknown.Device return status/follow up? no, discarded.".

• Brand Name: PRLNE BLU 24IN 6-0 D/A CC175-8 MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13863140
• Report Number: 2210968-2022-02034
• Device Sequence Number: 14631804
• Product Code: GAW
• UDI-Device Identifier: 10705031231719
• UDI-Public: 10705031231719
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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 Model Number: W8807
• Device Catalogue Number: W8807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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