MAUDE Adverse Event Report: ETHICON INC. STEEL SUTURE 18"(45CM) 7 B&S; SUTURE, NONABSORBABLE, STEEL

Catalog Number	D9499
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
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 a patient underwent an unknown procedure in 2019 and suture was used.It was reported that the needle deswaged during routine use.When the first one came off the needle driver, his hand flew up to hit him in his face / surgical glasses, contaminating the instrument as well as his glove / gown.He had to leave the or to clean his glasses / rescrub and re gown / glove.This potentially contaminated the operative field and delayed the case.Fortunately the needle driver did not injure his face because it hit the surgical glasses instead.Another device was used to complete the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot pcz883, and no non-conformances were identified.It was received for analysis an empty opened straight pack folder and detached needle.During the visual inspection of detached needle, the swage and attachment area were noted to be as expected and marks could be observed on the body needle that appear to be by use of a surgical instrument.No suture remnant was observed into the barrel hole and the suture was not received to determine the assignable cause.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, it could not be determined what may have caused the reported incident of: ¿it was reported that the needle deswaged during routine use¿.

• Brand Name: STEEL SUTURE 18"(45CM) 7 B&S
• Common Device Name: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9268643
• Report Number: 2210968-2019-89407
• Device Sequence Number: 19266237
• Product Code: GAQ
• UDI-Device Identifier: 10705031033313
• UDI-Public: 10705031033313
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 10/09/2019

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: 02/29/2024
• Device Catalogue Number: D9499
• Device Lot Number: PCZ883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/11/2019
• Patient Sequence Number: 1