MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8307
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) 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 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.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.Could you please confirm if the patient suffer from any consequence due to the issue? please provide more details.In attached file indicate surgery prolonged, could you please confirm this next questions: was there any change in the patient¿s post-operative care due to the prolonged procedure? were there any unexpected outcomes or complications as a result of the prolonged surgery time? how long (in minutes) did the surgery prolong? events reported via: 2210968-2022-06638, 2210968-2022-06637, this report.
Event or Problem Description
It was reported that a patient underwent gastric procedure on (b)(6) 2022 and suture was used.During the procedure, the surgeon reported that three sutures detached from the needle at the surgery intra-op as he was performing a laparoscopic gastric bypass at the (b)(6) bariatric centre.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/27/2022.H6 component code: g07002 no device returned.Additional information: h3, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: the patient did not suffer any consequences due to the issue.There was no change in the patient¿s post-operative care due to the prolonged procedure.There was no unexpected outcomes or complications because of the prolonged surgery time.The surgery was prolonged by 15minutes due to the issue.- please also note that there was cost implication on the customer due to the issue and they were requesting for replacement of the sutures.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 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.Events reported via: 2210968-2022-06638, 2210968-2022-06637, 2210968-2022-06636.

• Brand Name: PROLENE SUTURE 30"(75CM) 6-0 BLU
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15230556
• Report Number: 2210968-2022-06636
• Device Sequence Number: 17307170
• Product Code: GAW
• UDI-Device Identifier: 10705031045668
• UDI-Public: 10705031045668
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• 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,Followup
• Report Date (Section B): 09/27/2022

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: M8307
• Device Catalogue Number: M8307
• Device Lot Number: RMBCDL
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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 Age: 32 YR
• Patient Sex: Female
• Patient Weight: 140 KG