MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 18IN 5-0 S/A PS-3 PRM MP; SUTURE, ABSORBABLE, NATURAL

Model Number	1636G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Not Applicable (3189)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances related to the reported complaint condition were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to clarify 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.What instruments were used to grasp the needle? how was the needle grasped and how was control lost of the needle? what is physician¿s opinion as to the etiology of or contributing factor to this event? what is a device return status?.
Event or Problem Description
It was reported that the patient underwent a left buccal mucosa laceration repair under moderate sedation in the emergency department on (b)(6) 2020 and the suture was used.When during the first pass/suture, the suture material separated from the needle.The repair procedure was immediately stopped, and the recovery of the needle was attempted by the ed provider team as well as with a consulting pediatric surgeon, without success.The needle became lodged in the cheek mucosa and was verified with x-ray.Rather than continue to attempt in the ed, the patient was moved to or for patient safety in a controlled environment.The patient underwent a retrieval and extraction, left buccal space needle, with repair of left buccal mucosal laceration in the or.The patient was discharged to home in stable condition with parents.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 9/9/2020.Additional information was requested and the following was obtained: what instruments were used to grasp the needle? - we used a standard non-disposable surgical grade needle holder that is contained in our sterilized suture kits.How was the needle grasped and how was control lost of the needle? - needle was grasped on the body, ~50% from the needle tip (not on the swage).Needle was lost when it rotated in the soft tissue while grabbing the tip.What is physician¿s opinion as to the etiology of or contributing factor to this event? - per md: ¿ i think there was a defect in the swage portion of the needle which was never traumatized by our instruments.We did not pull in a retrograde fashion on the suture either.¿ what is a device return status? the device was removed in the or and disposed.Device will not be returned as was disposed of.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: GUT CHR UD 18IN 5-0 S/A PS-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10461437
• Report Number: 2210968-2020-06436
• Device Sequence Number: 11349036
• Product Code: GAL
• UDI-Device Identifier: 10705031001497
• UDI-Public: 10705031001497
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 1636G
• Device Catalogue Number: 1636G
• Device Lot Number: LL6801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 MO