MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP. AKA STRYKER ORTHOPAEDICS BIO PREP BONE PREPARATION KIT; CEMENT OBTURATOR

Catalog Number 0206-710-000

Device Problems Entrapment of Device (1212); Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/18/2019

Event Type  Injury  

Event Description

The plastic tool in the cement restrictor set became lodged in the femur.After several attempts to remove, the piece broke leaving the end still attached to the restrictor.Decision made to leave it inside.

• Brand Name: BIO PREP BONE PREPARATION KIT
• Type of Device: CEMENT OBTURATOR
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP. AKA STRYKER ORTHOPAEDICS
• MDR Report Key: 8749254
• MDR Text Key: 149836473
• Report Number: MW5087713
• Device Sequence Number: 1
• Product Code: LZN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Catalogue Number: 0206-710-000
• Device Lot Number: 18311012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 54