MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 5"(13CM) 10-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	2850G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mcm397 batch number, and no non-conformances were identified.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.Procedure name? what do you mean by "top of suture broke off during use and lost"? did the needle break and fall into patient? if yes, was it removed? and how? if not, does a needle piece still remain in patient? and what location? has there been any medical/surgical intervention done on patient or planned at a later date to remove needle piece? any post-op patient consequence / ae outcome as a result of the event? patient current condition?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The top of suture broke off during use and lost.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional information was requested and the following was obtained: what is meant by "top of suture broke off during use and lost"? ¿tip of needle broke ¿ think it was user error¿ did the needle break and fall into patient? ¿tip of the needle broke.Not sure if it fell into patient¿ if yes, was it removed? and how? if not, does a needle piece still remain in patient? and what location? ¿it was hand surgery ¿ unlikely that the needle tip is still in the patient¿ procedure name? ¿hand surgery¿ has there been any medical/surgical intervention done on patient or planned at a later date to remove needle piece? ¿no¿ any post-op patient consequence / ae outcome as a result of the event ? ¿none reported¿ patient current condition? ¿unknown¿.

• Brand Name: ETHILON SUTURE 5"(13CM) 10-0 BLK
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8941248
• Report Number: 2210968-2019-86388
• Device Sequence Number: 19354782
• Product Code: GAR
• UDI-Device Identifier: 10705031004139
• UDI-Public: 10705031004139
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/05/2019

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: 02/28/2023
• Device Catalogue Number: 2850G
• Device Lot Number: MCM397
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 09/25/2019
• Patient Sequence Number: 1