MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 3-0 S/A RB-1; SUTURE, ABSORBABLE, NATURAL

Catalog Number	U204H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 a dental procedure on (b)(6) 2018 and suture was used.During the procedure, the needle came off of the suture under very little tension.The surgeon never lost possession of the needle.Another like device was used to complete the procedure.There were no adverse consequences for the patient.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.The actual sample product was returned for analysis.During the visual inspection of the suture, a fracture was observed at the suture attachment of the needle.One side of the needle was received, the mating fracture surface was not provided.The fracture surfaces and surrounding area of the needle were examined in multiple locations under microscopy.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.This was a ductile fracture.The manufacturing records couldn't be reviewed as the batch number is unknown.Per the condition of the sample received, it was observed the breakage occurred at the attachment area of the needle during use due to tensile overload which corresponds to the reported complaint.

• Brand Name: GUT CHR UD 27IN 3-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7712298
• Report Number: 2210968-2018-74568
• Device Sequence Number: 2643832
• Product Code: GAL
• UDI-Device Identifier: 10705031051140
• UDI-Public: 10705031051140
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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 Catalogue Number: U204H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 09/13/2018
• Patient Sequence Number: 1