MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MAESTRO LARGE FIXED DURAGUARD; MOTOR, DRILL, PNEUMATIC

Catalog Number 5400210059

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2013

Event Type  malfunction  

Event Description

It was reported that the foot of the maestro large fixed duraguard was not straight during service inspection at the manufacturing facility.No patient involvement, no adverse consequences, no medical intervention, and no surgical delay were reported with this event.

Manufacturer Narrative

During failure analysis, the reported event of a duraguard foot not being straight was confirmed by the technician through visual evaluation.A bent duraguard can occur if excessive side load was applied to the feature.The device was discarded by the manufacturer following evaluation.

• Brand Name: MAESTRO LARGE FIXED DURAGUARD
• Type of Device: MOTOR, DRILL, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3556471
• MDR Text Key: 16779787
• Report Number: 0001811755-2014-00039
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5400210059
• Device Lot Number: 09237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2013
• Date Manufacturer Received: 12/18/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1