MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 30"(75CM) 3-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	1673H
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch (b)(4), and no non-conformances were identified 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2020, it was found that the sterile package had been damaged from the beginning.Further details are not provided from the healthcare professional.There was no patient involvement reported.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: ETHILON SUTURE 30"(75CM) 3-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10326261
• Report Number: 2210968-2020-05573
• Device Sequence Number: 11321415
• Product Code: GAR
• UDI-Device Identifier: 10705031001923
• UDI-Public: 10705031001923
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

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: 10/31/2023
• Device Model Number: 1673H
• Device Catalogue Number: 1673H
• Device Lot Number: MMP859
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 07/27/2020
• Patient Sequence Number: 1