MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 36IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP946H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a total hip replacement procedure on (b)(6), 2021 and suture was used.During the procedure, a small piece of the needle broke off in the patient.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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: what is the procedure & event date? (b)(6), total hip replacement could you please confirm what consequences did the patient present? please explain.No issues for patient and x-ray didn¿t show needle very well although it was a very small piece and you had to look close to see it.What is the lot number? i would have to look back in the chart.It was either an o-vicryl ct-1 or ethibond- unknown lot.What do you mean by "mri"? please explain our imaging supervisor was concerned if the piece that was retained would cause any harm when patient would have mri which is why i had inquired about what the needle was made of.Did pieces get retrieved? when it was noticed that a small piece of it had broke off the surgeon was notified and he declined x-ray due to the size and there was a lot of irrigation used so may have irrigated the piece out.What was used to complete the procedure? new needle used to close wound from total hip.What tissue structure is it located? within soft tissue facia at hip.Size of the needle piece retained? it was not entire needle only a very small piece of it.Are any plans in place to remove the needle piece in future? no future surgery planned due to what i explained above.If retained, what is the surgeon's opinion of consequences to the patient? no concerns from the surgeon.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 275 g/m.
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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: what is the procedure & event date? nov.22nd, total hip replacement could you please confirm what consequences did the patient present? please explain.No issues for patient and x-ray didn¿t show needle very well although it was a very small piece and you had to look close to see it.What is the lot number? i would have to look back in the chart.It was either an o-vicryl ct-1 or ethibond- unknown lot.What do you mean by "mri"? please explain our imaging supervisor was concerned if the piece that was retained would cause any harm when patient would have mri which is why i had inquired about what the needle was made of.Did pieces get retrieved? when it was noticed that a small piece of it had broke off the surgeon was notified and he declined x-ray due to the size and there was a lot of irrigation used so may have irrigated the piece out.What was used to complete the procedure? new needle used to close wound from total hip.What tissue structure is it located? within soft tissue facia at hip.Size of the needle piece retained? it was not entire needle only a very small piece of it.Are any plans in place to remove the needle piece in future? no future surgery planned due to what i explained above.If retained, what is the surgeon's opinion of consequences to the patient? no concerns from the surgeon.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 275 g/m.
Event or Problem Description
It was reported that a patient underwent a total hip replacement procedure on (b)(6), 2021 and suture was used.During the procedure, a small piece of the needle broke off in the patient.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL+ UD 36IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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
• MDR Report Key: 13043456
• Report Number: 2210968-2021-12757
• Device Sequence Number: 12118541
• Product Code: GAM
• UDI-Device Identifier: 10705031056145
• UDI-Public: 10705031056145
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

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 Model Number: VCP946H
• Device Catalogue Number: VCP946H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/20/2021
• 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