MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 27IN 4-0 S/A SH-1; SUTURE, ABSORBABLE, NATURAL

Model Number	G181H
Medical Device Problem Code	Break (1069)
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
(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 the patient underwent an unknown procedure in 2019 and suture was used.The thread of the suture is easy to break during suturing.Another device from a different lot was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Date sent to the fda: 02/05/2020.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.H-3 summary: one open sample of product was received for analysis.During the visual inspection of sample, the swage and attachment area were noted to be as expected.The barrel hole was examined for suture remnant and it was observed crushed.Marks on edge needle the end suture was cut appears to be by use of a surgical instrument.Marks were observed on the edge of the needle.According the sample condition, the assignable cause of performance breakage suture suggest an improper handling of the sample.In order to avoid this kind of damage the packages insert (ifu) cautions: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.Also, as with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.

• Brand Name: GUT CHR UD 27IN 4-0 S/A SH-1
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9577534
• Report Number: 2210968-2020-00265
• Device Sequence Number: 2197586
• Product Code: GAL
• UDI-Device Identifier: 10705031037557
• UDI-Public: 10705031037557
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/16/2019

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 Model Number: G181H
• Device Catalogue Number: G181H
• Device Lot Number: PCM918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1