MAUDE Adverse Event Report: STRYKER INSTRUMENTS CAST CUTTER; INSTRUMENT, CAST REMOVAL, AC-POWERED

Model Number 940

Device Problem Unintended Movement (3026)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 03/26/2015

Event Type  No Answer Provided  

Event Description

Patient was present to have a serial cast removed from her right foot.Mom was seated with patient on mat table holding her upper body while staff stabilized her right leg to remove cast.Staff began cast cutting at medial, distal foot and completed to top of the cast.When staff began cutting other side of cast (lateral aspect at toes), other staff pointed out blood dripping from cast near right medial ankle.Finished removing cast with saw as we could not see what was going on.After cutting lateral aspect of cast without incident, cast material was removed and noted laceration at right navicular.Patient's wound was cleaned, dressed and wrapped and mom took patient to ed per recommendation of therapist.

• Brand Name: CAST CUTTER
• Type of Device: INSTRUMENT, CAST REMOVAL, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 e. milham avenue; kalamazoo MI 49001
• MDR Report Key: 4758273
• MDR Text Key: 5789219
• Report Number: 4758273
• Device Sequence Number: 1
• Product Code: LGH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Model Number: 940
• Device Catalogue Number: 940
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2015
• Device Age: 2 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 28