MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 18IN 6-0 S/A G-1 PRM; SUTURE, ABSORBABLE, NATURAL

Model Number	796G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please verify the issue; were suture threads breaking? specific number of devices that failed in this procedure? when did each device fail; in the package/ during handling (before use on patient)/during actual suturing (use on patient)? how was case completed? please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the following information.To date no response has been provided.If 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 an unknown procedure on an unknown date and suture was used.During the procedure, the suture was tearing.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: please verify the issue; were suture threads breaking? specific number of devices that failed in this procedure? when did each device fail; in the package/ during handling (before use on patient)/during actual suturing(use on patient) how was case completed? please provide the status of the device(s) as it has not been received for analysis.The sutures were breaking every time we tried to tie a knot.We had about 15 sutures break opening new boxes as well.They would break during surgery.We used different sutures.Note: events reported via mw # 2210968-2019-88929, 2210968-2020-01449, 2210968-2020-01450, 2210968-2020-01451, 2210968-2020-01452, 2210968-2020-01453, 2210968-2020-01454, 2210968-2020-01455, 2210968-2020-01456, 2210968-2020-01457, 2210968-2020-01458, 2210968-2020-01459, 2210968-2020-01460, 2210968-2020-01461, 2210968-2020-01462.

• Brand Name: GUT CHR UD 18IN 6-0 S/A G-1 PRM
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9220583
• Report Number: 2210968-2019-88929
• Device Sequence Number: 2801336
• Product Code: GAL
• UDI-Device Identifier: 10705031011946
• UDI-Public: 10705031011946
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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: 10/31/2023
• Device Model Number: 796G
• Device Catalogue Number: 796G
• Device Lot Number: MM6533
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1