MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 5-0 S/A P-2 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J503G
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).A manufacturing record evaluation was performed for the finished device pcm110 batch number, and no non-conformances were identified.Attempts are being 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.Were both lots total quantity 2 device involved in same procedure? device return status/ follow up note: events reported via mw # 2210968-2019-89855, 2210968-2019-89856.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.The needle was broken.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: were both lots total quantity 2 device involved in same procedure? yes.Will the product be returned for investigation? yes.Note: events reported via mw # 210968-2019-89856.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/06/2020.Additional h3 investigation summary: no product was returned for evaluation to determine the assignable cause of the it was reported performance needle breakage; therefore, the reported failure could not be evaluated.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.It could not be determined what may have caused the reported incident of needle breakage.Additional information was requested and the following was obtained: 1.Were both lots total quantity 2 device involved in same procedure? yes.Note: events reported via mw # 2210968-2019-89855, 210968-2019-89856.

• Brand Name: VCL CT BRD UD 18IN 5-0 S/A P-2 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9310952
• Report Number: 2210968-2019-89856
• Device Sequence Number: 11352954
• Product Code: GAM
• UDI-Device Identifier: 10705031040717
• UDI-Public: 10705031040717
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K022269
• 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,Followup
• Report Date (Section B): 10/22/2019

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 Catalogue Number: J503G
• Device Lot Number: PCM110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/16/2019; 12/10/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 12/06/2019; 01/06/2020
• Patient Sequence Number: 1