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

Model Number	2870G
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mgk898, 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.Additional information was requested and the following was obtained: confirm the specific number of devices or total qty actually involved and reported for suture diameter issue ? => no further information is available.Confirm the suture diameter issue is related to one suture piece and not component mix ? => no further information is available.No further information will be provided.
Event or Problem Description
It was reported that a patient underwent an unknown neuro surgery on (b)(6) 2020 and suture was used.During the procedure, when opening the package, it was found that the suture was thicker than usual.There were no adverse consequences to the patient.No additional information was provided.

• Brand Name: ETHILON SUTURE 5"(13CM) 10-0 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: 9726917
• Report Number: 2210968-2020-01276
• Device Sequence Number: 11494795
• Product Code: GAR
• UDI-Device Identifier: 10705031004160
• UDI-Public: 10705031004160
• 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): 01/23/2020

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: 05/31/2023
• Device Model Number: 2870G
• Device Catalogue Number: 2870G
• Device Lot Number: MGK898
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/19/2020
• Patient Sequence Number: 1