MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 8X18IN 5-0 S/A RB-1 CR MP; SUTURES - ABSORBABLE

Catalog Number	Z711D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device jg6831 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 the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on unknown date and the suture was used.During use, the suture was broken.Another like suture was used.There were no adverse consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Device evaluation summary: an empty opened foil, a paper lid and a winding former with eight needles and suture pieces of product code z711d, lot # mg6831 were returned for analysis.During the visual inspection of sample, the swage and attachment area of the eight needles were noted to be as expected and a piece of the suture was noted attach to barrel hole in each needle, the sutures has begun with the process of degradation and the strands was broken in multiples pieces, this is the cause that breakage suture.The product code z711d contains absorbable sutures and as the sample was received open, the time of exposure of suture to the environment could not be determined and no functional test can be performed due to sample condition.The foil was inspected and multiples holes in cavity were noted.This condition contributed to degradation of the suture.The conditions of the holes could not be determined.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition the assignable cause of performance breakage suture, was caused by suture degradation exposure to environment.

• Brand Name: PDSII VIO 8X18IN 5-0 S/A RB-1 CR MP
• Common Device Name: SUTURES - ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 9038791
• Report Number: 2210968-2019-87354
• Device Sequence Number: 2411067
• Product Code: NEW
• UDI-Device Identifier: 10705031061590
• UDI-Public: 10705031061590
• 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): 08/19/2019

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: 05/31/2020
• Device Catalogue Number: Z711D
• Device Lot Number: JG6831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1