MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 1 S/A CTXB; SUTURE, SURGICAL, ABSORBABLE

Model Number	ZB371
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that a patient underwent an unknown orthopedic surgery on (b)(6) 2020 and suture was used.During the procedure, after opening the package, the needle was detached from the suture easily when trying to use it.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 4/24/2020.Additional h3 investigation summary: it was reported pull off - suture needle.One empty opened folder, a detached needle and one dispensed suture of product code zb371 were received for analysis.During the visual inspection of the needle the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined under 20x magnification and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement. the manufacturing records could not be reviewed as the batch number is unknown.Per the sample condition, the assignable cause of the performance pull off - suture needle is a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use.

• Brand Name: PDSII VIO 36IN 1 S/A CTXB
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9843295
• Report Number: 2210968-2020-02160
• Device Sequence Number: 2636697
• Product Code: NEW
• UDI-Device Identifier: 10705031062078
• UDI-Public: 10705031062078
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• 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): 02/21/2020

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: ZB371
• Device Catalogue Number: ZB371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/24/2020
• Patient Sequence Number: 1