MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 30IN 5-0 D/A RB-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z148H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.(b)(4).To date it has been reported that the device will not be returned.If the device or further details are received as 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 the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? please describe any medical/surgical intervention required for this suture event including dates and results.Please clarify: did the needle pull off the suture or did the needle break? does the needle remain retained in the patient? if yes, what tissue structure is it located? if yes, is it the whole needle that was retained? size of the needle retained? are any plans in place to remove the needle piece in future? if retained, what is the surgeon's opinion of consequences to the patient? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used for wound closure.During the procedure, the suture pulled off the needle, causing the needle to be missing.When the needle was found missing, the doctor immediately stopped closing the abdomen to find the broken needle, and the operator took corresponding measures to use x-ray power off fluoroscopy.The operating room included the abdominal cavity to find the broken needle, but it was not found.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/17/2023.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.The following information was requested but unavailable: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? please describe any medical/surgical intervention required for this suture event including dates and results.Please clarify: did the needle pull off the suture or did the needle break? does the needle remain retained in the patient? if yes, what tissue structure is it located? if yes, is it the whole needle that was retained? size of the needle retained? are any plans in place to remove the needle piece in future? if retained, what is the surgeon's opinion of consequences to the patient? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 2/15/2023.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 obtained: after investigation, the detached needle was finally found in the surgical room (specific location is unknown).This event did not cause any other harm to the patient except for prolonged surgery time (specific prolongation time was unknown), and no subsequent adverse event report was received.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.Was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? if yes, please explain.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? what is the patients current status? (b)(4).Corrected information: b1, b2, h1, h6 health effect clinical code, h6 health effect - impact code.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 2/17/2023.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.The following information was requested but unavailable: was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? if yes, please explain.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? what is the patients current status?.

• Brand Name: PDSII VIO 30IN 5-0 D/A RB-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16112571
• Report Number: 2210968-2023-00132
• Device Sequence Number: 5754190
• Product Code: NEW
• UDI-Device Identifier: 10705031060272
• UDI-Public: 10705031060272
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: Z148H
• Device Catalogue Number: Z148H
• Device Lot Number: MHM819
• 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: 12/26/2022
• Supplement Date Received by Manufacturer: 01/11/2023; 02/07/2023; 02/17/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 01/17/2023; 02/15/2023; 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Male