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

Model Number	Z507G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an unknown dermatologic surgery on (b)(6) 2021 and suture was used.During the procedure, the needle tip was broken.At that time, it was judged that there was no residue in the body and the wound was closed.However, one week after the surgery, an x-ray revealed that it was in the dermis.How to proceed is under discussion currently, and it is highly likely that a reoperation will be performed for removal.The patient's condition was good after the initial surgery.No secondary health hazard due to retained needle has been identified.Though the needle piece is still left in patient, the patient is stable.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).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 current condition of the patient? though the needle piece is still left in patient, the patient is stable.Was there any additional tissue damage as a result of searching for the needle piece? no.What measures will be taken to retrieve the broken piece? highly likely to be removed by re-operation.Are any plans in place to remove the needle piece in future? if yes, please indicate when (mm/dd/yyy): how to proceed is under discussion currently, and it is likely that reoperation will be performed for removal.Date is unknown.- what is the surgeon's opinion of consequences to the patient? no further information is available.What is the lot number? unknown.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 11/30/2021.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.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 date and 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)? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? 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)? what instruments were used to grasp the needle? where was the needle grasped during use? what was the size of the needle used? please describe any medical/surgical intervention required for this suture event including dates and results.Was the needle piece removed or is it planned to be removed? if yes, when was removed and provide details of removal intervention or provide date of the planned procedure.What is the patient¿s current status? please provide lot number if available.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 12/28/2021.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: date and name of index surgical procedure? procedure date is (b)(6) 2021.What was the size of the needle used?16mm.Was the needle piece removed or is it planned to be removed? if yes, when was removed and provide details of removal intervention or provide date of the planned procedure.How to proceed is under discussion currently, and it is likely that reoperation will be performed for removal.Date is unknown.What is the patient¿s current status? as of now, no secondary damage has been observed before the reoperation.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 the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? 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)? what instruments were used to grasp the needle? where was the needle grasped during use? please describe any medical/surgical intervention required for this suture event including dates and results.Please provide lot number if available.

• Brand Name: PDSII CLR 18IN 4-0 S/A PS-4 PRM MP
• Common Device Name: 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: 12865555
• Report Number: 2210968-2021-11986
• Device Sequence Number: 16514299
• Product Code: NEW
• UDI-Device Identifier: 10705031061293
• UDI-Public: 10705031061293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2021

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 Model Number: Z507G
• Device Catalogue Number: Z507G
• 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: 10/29/2021
• Supplement Date Received by Manufacturer: 11/30/2021; 12/09/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 11/30/2021; 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown