MAUDE Adverse Event Report: ETHICON INC. SILK BLK 10X30IN 1 NON NDL; SUTURE, NONABSORBABLE, SILK

Model Number	SA87G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2022
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.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.The following information was requested, but unavailable: was there any adverse consequence associated with the patient? was there any change in the patient¿s post-operative care due to the prolonged procedure? were there any unexpected outcomes or complications as a result of the prolonged surgery time? how long (in minutes) did the surgery prolong? please confirm if there was postoperative bleeding: was there any adverse consequence associated with the patient? all answers above are unobtainable.Once there is any update, we will update the information.Mfr retained sample investigation summary: actual customer complaint sample or same batch representative sample are not returned.Same batch manufacturer retained sample evaluated for [appearance] and [tensile strength] per current version of sop-06-14 and no issue found, detail testing data please refers to investigation plan.Dhr reviewed and no issue found.The root cause of this complaint can¿t be determined, this complaint data will be kept for trend analysis.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Events reported via: 2210968-2022-05155 and 2210968-2022-05157.
Event or Problem Description
It was reported that a patient underwent a hysterectomy procedure on (b)(6) 2022 and suture was used.During the procedure, it was reported that suture broke during sewing vaginal wall in surgery.The procedure was vaginal hysterectomy + modified anterior pelvic floor suspension + middle urethral suspension + paravaginal repair + excision of posterior vaginal wall vegetation.Changed another two to continue the surgery, the same problem happened.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SILK BLK 10X30IN 1 NON NDL
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• 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: 14940685
• Report Number: 2210968-2022-05156
• Device Sequence Number: 12351789
• Product Code: GAP
• UDI-Device Identifier: 10705031050303
• UDI-Public: 10705031050303
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2022

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: SA87G
• Device Catalogue Number: SA87G
• Device Lot Number: RL2AL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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 Age: 66 YR
• Patient Sex: Female