MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 5"(13CM) 10-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	2820G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an orthopedic procedure on (b)(6) 2021 and suture was used.During the procedure, the needle broke.There were no patient consequences 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 following information was requested, but unavailable: please provide lot number? no further information is available.Did the broken tip fell inside the patient? if so, was it retrieved during the same procedure? no further information is available.What was done to retrieve the broken piece? no further information is available.Was additional dissection required in other organs/tissues other than the target tissue? no further information is available.Was there any additional tissue damage as a result of searching for the needle piece? no further information is available.Please clarify how the procedure was complete.No further information is available.If the needle remains in the patient, please specify: no further information is available.Size of the needle piece retained? in what structure/tissue was it retained? are there any future plans to remove it? no further information will be provided.

• Brand Name: ETHILON SUTURE 5"(13CM) 10-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12611465
• Report Number: 2210968-2021-09507
• Device Sequence Number: 6142802
• Product Code: GAR
• UDI-Device Identifier: 10705031004061
• UDI-Public: 10705031004061
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

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: 2820G
• Device Catalogue Number: 2820G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1