MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE; SUTURE, NONABSORBABLE, SILK

Catalog Number	C053D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2018
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, during an unknown dental procedure on (b)(6) 2018 suture was used.The needle was broken at the swage during use.The operation was completed by using another needle-suture from the same package.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Additional h3: representative sample evaluated, the swage and attachment area were as expected.In addition, no defects or needle breakage were observed at the tip and body of the needles.The suture was dispensed without problems and the two sutures were examined along of the strand and no defect were observed.The needle met the resistance test requirements.The actual failed suture needle was also evaluated.A fracture was observed in the body of the needle.The needle was received in two pieces.The fracture was composed of microvoid coalescence, which is evidence of a ductile overload failure.Mechanical damage, a cup-and-cone shaped fracture and macroscopic plastic deformation observed coincidental to the fracture provide additional evidence that the failure was induced by mechanical deformation leading to ductile overload.
Additional Manufacturer Narrative
Pc-(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

• Brand Name: SILK SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7313718
• Report Number: 2210968-2018-71269
• Device Sequence Number: 1801676
• Product Code: GAP
• UDI-Device Identifier: 10705031023635
• UDI-Public: 10705031023635
• 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,Followup,Followup
• Report Date (Section B): 02/13/2018

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 Expiration Date: 04/30/2022
• Device Catalogue Number: C053D
• Device Lot Number: LEP693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 03/07/2018; 04/04/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 03/26/2018; 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1