MAUDE Adverse Event Report: ETHICON INC. STRATAFIX PDS PLUS 18"(45CM) 3/0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A100
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).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 the patient underwent an unknown orthopedic procedure and suture was used.During the procedure, the suture broke.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
A needle-suture combination in two sections was received for analysis.During the visual inspection of sample, the swage and attachment area of the needle were as expected; marks on the body needle that appears to be by the use of a surgical instrument were noted.The suture pieces present body fluids on some the barbs.In addition, the ends of the suture pieces were cut.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.Additionally, the sample was tested by tensile strength and meets the finished goods requirements.Per the sample condition the assignable of the performance - breakage suture, suggest an improper handling of the sample.

• Brand Name: STRATAFIX PDS PLUS 18"(45CM) 3/0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7263081
• Report Number: 2210968-2018-70796
• Device Sequence Number: 1036531
• Product Code: NEW
• UDI-Device Identifier: 10705031227736
• UDI-Public: 10705031227736
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113004
• 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): 01/25/2018

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 Catalogue Number: SXPP1A100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1