MAUDE Adverse Event Report: DEPUY MITEK INC. OMNISPAN MENISCAL REPAIR SYSTEM

Lot Number 3859902

Device Problems Break (1069); Misfire (2532); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/25/2016

Event Type  malfunction  

Event Description

A (b)(6) male patient scheduled for right knee arthroscopy with meniscal repair.The surgeon used depuy-meniscal deployment gun with 2 omnispan anchors.The deployment gun misfired and broke in the patient's right knee.One implant is accounted for, but one implant was unaccounted for in the patient's knee, the suction canister, or on the operating room floor.The physician is aware and no harm came to the patient.

• Brand Name: OMNISPAN MENISCAL REPAIR SYSTEM
• Type of Device: OMNISPAN MENISCAL REPAIR SYSTEM
• Manufacturer (Section D): DEPUY MITEK INC. ; rayham MA
• MDR Report Key: 5764789
• MDR Text Key: 48786922
• Report Number: 5764789
• Device Sequence Number: 1
• Product Code: MBI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Lot Number: 3859902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2016
• Distributor Facility Aware Date: 05/25/2016
• Device Age: NA
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/05/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 122