MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 4-0 S/A P-3 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number Z494G

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown dermatologic procedure on an unknown date and suture was used.During subcutaneous implantation suture, the needle was broken at the swage part at the 3rd stitch.Since the broken needle was left in the patient's subcutaneous tissue, it was excised along with the surrounding tissue and the needle was removed.The wound was closed after tissue removal, and the patient is on track to be discharged.At the same time, the surgeon stuck the needle into his hand.There were no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: there were no adverse consequences to the patient.=> there were adverse consequences to the patient.Unknown, (b)(6), unknown, unknown dermatologic surgery.[event information correction]: original information: the suture was broken during suturing.At the same time, the surgeon stuck the needle into his hand.Corrected information: during subcutaneous implantation suture, the needle was broken at the swage part at the 3rd stitch.Since the broken needle was left in the patient's subcutaneous tissue, it was excised along with the surrounding tissue and the needle was removed.The wound was closed after tissue removal, and the patient is on track to be discharged.[health hazard details] in order to remove the leftover needle, the surrounding tissue was once removed.In order to remove the leftover needle, the surrounding tissue was once removed.No additional treatment is planned.[product use details] to perform subcutaneous implantation suture, instrument tying was performed in a cycle of applying needle in a deep area, putting needle out in a shallow area, applying needle in a shallow area, and putting needle out in a deep area.During the third stitch from the shallow area to the deep area, when the surgeon tried to put the needle back, only the suture and a small part of the broken swage part of the needle came out.Since it was thought that the broken needle had been left in the subcutaneous tissue, the surrounding tissue was removed, and the needle was removed.[the surgeon¿s comments] the needle broke, and the surrounding tissue had to be removed, but the surgeon himself realized that there may have been a problem with the position of the gripping of the needle, as explained by the sales representative.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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 01/25/2022.H6 component code: g07002 - device not returned.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: what was the name of the procedure? - unknown but dermatological surgery.What was the procedure date? - unknown.What is the lot number? - unknown.What is the current status of the surgeon? - no problem.Device return status: - no sample will be returned.According to the sales rep, the surgeon actually wasn't hurt.This incident was that the needle was broken at the in the operation and the fragment was buried subcutaneously in patient.Therefore, the needle piece was removed by excising the surrounding tissue.The patient is in good.

• Brand Name: PDSII CLR 18IN 4-0 S/A P-3 PRM MP
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• 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: 13102104
• MDR Text Key: 287261536
• Report Number: 2210968-2021-13035
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031061170
• UDI-Public: 10705031061170
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z494G
• Device Catalogue Number: Z494G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1