MAUDE Adverse Event Report: ETHICON INC. SILK BLK 30IN 0 S/A SH; SUTURE, NONABSORBABLE, SILK

Model Number	K834H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a pacemaker procedure on an unknown date in 2021 and suture was used.During the procedure, the suture is breaking while tying down the pacemaker.No adverse patient consequences were reported.Additional information was requested.
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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.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.What was the procedure date? what is the lot number? did the event occur during one or multiple patient procedures? what is the total number of procedures? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If this event occurred in multiple procedures, please provide the following information for each patient event: - what is the procedure name? - what is the procedure date? - do you have any pictures of the reaction? - was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.- if medication was required, please clarify if it was prescribed by a physician.What is the most current patient status? can you identify the product code and lot number of the product that was used?.

• Brand Name: SILK BLK 30IN 0 S/A SH
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12713738
• Report Number: 2210968-2021-10502
• Device Sequence Number: 1507521
• Product Code: GAP
• UDI-Device Identifier: 10705031044418
• UDI-Public: 10705031044418
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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: K834H
• Device Catalogue Number: K834H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1