MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS HOFFMAN II; EXTERNAL BONE FIXATION KIT

Catalog Number 4920-9-870

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

Patient Problem No Information (3190)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

While placing screws for the external fixator osteosythesis system driver tip broke off when dr was using during case.End stripped and left in end of screw per dr.

• Brand Name: HOFFMAN II
• Type of Device: EXTERNAL BONE FIXATION KIT
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS; 325 corporate dr.; mahwah NJ 07430
• MDR Report Key: 4634515
• MDR Text Key: 5575966
• Report Number: 4634515
• Device Sequence Number: 1
• Product Code: KTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 4920-9-870
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR