MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 4-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8699G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
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.A manufacturing record evaluation was performed for the finished device batch rbbdrk and no non-conformances were identified 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.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.Please provide procedure name and date.Can you please clarify if the needle pull-off occurs before use on patient, or during use on patient? can you please confirm how many sutures presented the alleged issue? please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail please provide status of product return.This single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts are being made to obtain the information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Note: events reported in 2210968-2021-06728, and 2210968-2021-06730.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle popped off the suture.When the surgeon went to straighten out the "string" so the suture could be used, the needle popped off.There were no adverse patient consequences reported.Additional information has been requested.

• Brand Name: PRLNE BLU 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12233630
• Report Number: 2210968-2021-06729
• Device Sequence Number: 4861115
• Product Code: GAW
• UDI-Device Identifier: 10705031019263
• UDI-Public: 10705031019263
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

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: 01/31/2026
• Device Model Number: 8699G
• Device Catalogue Number: 8699G
• Device Lot Number: RBBDRK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/27/2021
• Patient Sequence Number: 1