MAUDE Adverse Event Report: ETHICON INC. SILK BLK 18IN 5-0 S/A P-3 PRM MP; SUTURE, NONABSORBABLE, SILK

Model Number	640G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Event or Problem Description
It was reported that an animal underwent an unknown surgery on (b)(6) 2021 and suture was used.During the procedure, the suture broke.No adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SILK BLK 18IN 5-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11998682
• Report Number: 2210968-2021-05529
• Device Sequence Number: 3305401
• Product Code: GAP
• UDI-Device Identifier: 10705031007369
• UDI-Public: 10705031007369
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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 Expiration Date: 06/30/2022
• Device Model Number: 640G
• Device Catalogue Number: 640G
• Device Lot Number: LHR926
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1