MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS CONQUEST; ACCESSORIES,ARTHROSCOPIC

Catalog Number 300-027-703

Device Problems Break (1069); Detachment Of Device Component (1104); Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 06/12/2017

Event Type  malfunction  

Event Description

During a right elbow arthroscopic debridement and removal of loose bodies with open debridement of the posterior olecranon & humeral osteophytes, the stryker arthroscopy soft tissue grasper broke off into the patient's elbow.The piece was retrieved and matched to ensure that nothing was left in the patient.

• Brand Name: CONQUEST
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS; 5900 optical court; san jose CA 95138
• MDR Report Key: 6910251
• MDR Text Key: 88015852
• Report Number: 6910251
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• 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: 09/19/2017

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
• Device Operator: Physician
• Device Catalogue Number: 300-027-703
• Device Lot Number: 9288D
• 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: 09/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AT THE TIME OF THE EVENT, THE PATIENT WAS UNDERGOI
• Patient Age: 53 YR
• Patient Weight: 86