MAUDE Adverse Event Report: ETHICON ETHICON STRATAFIX; SUTURE NEEDLE

Model Number	SXPD2B405
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Pt had an oxford unicompartmental arthroplasty left knee, patelloplasty.The wound was closed in layers and a sterile dressing was applied.While the staff were getting the pt ready for routine post op xrays, the operating room scrub nurse noticed that the tip of 1 of the suture needles to be missing.C-arm xray showed a questionable abnormal metallic density.The dressing was removed, the knee re-prepped and draped, and the wound opened in the central portion where the questionable metallic body was identified.A thorough inspection of the wound and joint space was carried out.Wound irrigated with copious amounts of saline.No metallic debris was found.A c-arm xray was again used to image the knee in multiple planes, and no metallic foreign body was found.The polyethylene bearing was placed back into the knee and the wound was once again irrigated and closed.

• Brand Name: ETHICON STRATAFIX
• Common Device Name: SUTURE NEEDLE
• Manufacturer (Section D): ETHICON
• MDR Report Key: 6854418
• Report Number: MW5072067
• Device Sequence Number: 19003594
• Product Code: GAM
• UDI-Device Identifier: 10705031207981
• UDI-Public: 10705031207981
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: SXPD2B405
• Device Lot Number: AAAJ115
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Weight: 81