MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 7-0 S/A P-6 PRM; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8648G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, the suture broke.Another like device was used to complete the procedure.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The following information was requested, but was unavailable: please provide procedure name please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail ----------------------------- all answers above are unknown.Once there is any update, we will update the information.Attempts have been 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.

• Brand Name: PRLNE BLU 18IN 7-0 S/A P-6 PRM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12674056
• Report Number: 2210968-2021-10019
• Device Sequence Number: 11123226
• Product Code: GAW
• UDI-Device Identifier: 10705031018365
• UDI-Public: 10705031018365
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,o
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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 Expiration Date: 05/31/2024
• Device Model Number: 8648G
• Device Catalogue Number: 8648G
• Device Lot Number: PGP093
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR