MAUDE Adverse Event Report: ETHICON INC. SILK SUTURE 30"(75CM) 4-0 BLK; SUTURE, NONABSORBABLE, SILK

Catalog Number	K952H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Additional information was requested and the following was obtained: did all devices had issue during actual use on patient? yes.How was case completed? no information.No further information will be provided.
Event or Problem Description
It was reported that a patient underwent a dental graft procedure on an unknown date and suture was used.During the procedure, the needle detached from the suture easily.There were no adverse consequences to the patient.Additional information had been requested.
Additional Manufacturer Narrative
The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.A paper lid, a winding former with a suture partially dispensed of product was returned for analysis.During the visual inspection of sample, the suture was totally dispensed and examined along of strand and no defects or damage was observed.The swage end was examined and it was noted sufficient impression at the swage area.Also, the needle was not received for determined the causa assignable.As no conclusion could be reached as to what may have caused the reported incident, the assignable cause of the reported complaint could not be determined.

• Brand Name: SILK SUTURE 30"(75CM) 4-0 BLK
• 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: 7515107
• Report Number: 2210968-2018-72798
• Device Sequence Number: 1169721
• Product Code: GAP
• UDI-Device Identifier: 10705031044760
• UDI-Public: 10705031044760
• 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): 04/21/2018

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: 05/31/2022
• Device Catalogue Number: K952H
• Device Lot Number: LGP643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Received by Manufacturer: 04/21/2018
• Supplement Date Received by Manufacturer: 05/15/2018; 06/04/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 05/30/2018; 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1