MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 18IN 5-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, NATURAL

Model Number	687G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
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.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.Additional information was requested and the following was obtained: was the suture package dry? yes- the packaging was dry and the expected wetness/fluid was not present.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.Were all 3 samples of product code 687g and 35 of product code 1824h for (b)(4).Observed with "dry packages and brittle/easy breakage of two suture" ? please provide the quantity with observed issue for each ip.Should these quantities need to be in the field of quantity to be returned and not in quantity of product involved? how many sutures are broken in each box in this single procedure during use or pre-op? lot number for product code 1824h? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Events reported in 2210968-2021-07658.
Event or Problem Description
It was reported that a patient underwent a septoplasty surgery on (b)(6) 2021 and suture was used.During the procedure, dry package was noted with easy breakage of suture.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: GUT CHR UD 18IN 5-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12364390
• Report Number: 2210968-2021-07657
• Device Sequence Number: 11737800
• Product Code: GAL
• UDI-Device Identifier: 10705031008304
• UDI-Public: 10705031008304
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: 02/28/2026
• Device Model Number: 687G
• Device Catalogue Number: 687G
• Device Lot Number: RCMJBD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1