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

Model Number	H820G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that the patient underwent a rhinoplasty surgery in 2019 and the suture was used.It was reported that the needle broke off the suture.The surgery was completed successfully with delay in 2 minutes.There were no patient's consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d10, h6.Additional h3 device evaluation summary: an open sample with a detached needle of product code h820 was returned for analysis.During the visual inspection of detached needle, the swage and attachment area were noted to be as expected and no suture remnant could be observed at the barrel hole, the end of the suture was examined and there isn¿t enough impression at the swage end, resulting in a needle pull off defect.The manufacturing records couldn't be reviewed as the batch number is unknown.Per the condition of the sample received, the assignable cause of the performance pull off suture needle, was a light swage, this defect is caused when does not tightens the press correctly and the swage area be weak on the needle/suture.

• Brand Name: GUT PL 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
• MDR Report Key: 9593216
• Report Number: 2210968-2020-00413
• Device Sequence Number: 491649
• Product Code: GAL
• UDI-Device Identifier: 10705031037762
• UDI-Public: 10705031037762
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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 Model Number: H820G
• Device Catalogue Number: H820G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1