MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 5-0 S/A FS-2; SUTURE, ABSORBABLE, NATURAL

Catalog Number	634G
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 by that during a veterinarian procedure on (b)(6) 2018, suture was used.During the procedure, the needle of suture bent the suture separated from the needle at the swage.The procedure was completed another suture.No additional information is available.
Additional Manufacturer Narrative
Pc-(b)(4).
Additional Manufacturer Narrative
(b)(4).An actual sample was returned for evaluation.During the visual inspection of the opened sample, the channel of the needle was open resulting in an incorrect swage and the cause of the detached.In addition, the shape of the needle was distorted at middle of the body and marks that appears to be by use of surgical instruments were found.Due to this damage, the comparison test of the needle with the drawing was not met.The suture was not returned for analysis.According to the sample condition the assignable cause of performance pull off suture needle, is an open channel defect.Representative samples were returned for analysis.During the visual inspection of unopened samples, the sample was opened and the swage and attachment area of the needle were not as expected; since open channel was observed in the needle resulting in an incorrect swage defect.The suture was dispensed without problems and examined along of the strand and no defects were observed.Also, the curve of the needle was comparison with the drawing of needle specification and fall within of curve tolerance shadow lines.The sample was tested by needle pull and meet the finished goods requirements.

• Brand Name: GUT CHR UD 27IN 5-0 S/A FS-2
• 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: 7400748
• Report Number: 2210968-2018-71943
• Device Sequence Number: 16511647
• Product Code: GAL
• UDI-Device Identifier: 10705031007130
• UDI-Public: 10705031007130
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2018

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: 08/31/2022
• Device Catalogue Number: 634G
• Device Lot Number: LKM459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 03/27/2018; 04/24/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 04/25/2018; 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1