MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 4-0 D/A SH-1 MP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	EH7585H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (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.H6 component code: g07002 device not returned 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.Did the needle fall into the patient? if yes, were x-rays taken to locate the needle piece(s)? what measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the needle piece? what tissue structure the broken needle was located? what is the surgeon's opinion of consequences to the patient? were there any unexpected outcomes or complications as a result of the prolonged surgery time? what tissue was being sutured when the event occurred? was additional dissection required in other organs/tissues other than the target tissue? was there any change in the patient¿s post operative care due to the prolonged procedure? please provide the lot number:.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2024 and suture was used.During the surgery, the needle broke at the body part during anastomosis on pancreas.The surgeon looked for the broken needle and eventually the broken needle was found in the body.The operation time was extended within 30 minutes.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (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.Additional information was requested and the following was obtained: were x-rays taken to locate the needle piece(s)? unk.What measures were taken to retrieve the broken piece? unk.Was there any additional tissue damage as a result of searching for the needle piece? no.What tissue structure the broken needle was located? unk.What is the surgeon's opinion of consequences to the patient? unk.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? no.What tissue was being sutured when the event occurred? pancreas.Was additional dissection required in other organs/tissues other than the target tissue?no.Was there any change in the patient¿s post operative care due to the prolonged procedure? no.Please provide the lot number: unk.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections; we regularly contact with sales rep about the device returning.Please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu); (b)(6).

• Brand Name: PRLNE BLU 36IN 4-0 D/A SH-1 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 ; 9083863534
• MDR Report Key: 18608814
• Report Number: 2210968-2024-00800
• Device Sequence Number: 2845285
• Product Code: GAW
• UDI-Device Identifier: 10705031097254
• UDI-Public: 10705031097254
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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 Catalogue Number: EH7585H
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 02/22/2024
• 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