MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LOANER CORE IMPACTION DRILL; DRIVER, WIRE, AND BONE DRILL, MANUAL

Catalog Number 5400300000L

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 05/12/2014

Event Type  Injury  

Event Description

It was reported that at the end of a procedure at the user facility, the end of the loaner core impaction drill got very hot, blistering the lip of the patient.The procedure was completed successfully with no delay.Triple antibiotic ointment was applied to the blister.Upon follow up, the user facility was not able to provide any further information regarding the reported event.

Event Description

It was reported that at the end of a procedure at the user facility the end of the loaner core impaction drill got very hot, blistering the lip of the patient.The procedure was completed successfully with no delay.Triple antibiotic ointment was applied to the blister.Upon follow up, the user facility was not able to provide any further information regarding the reported event.

Manufacturer Narrative

Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.

Manufacturer Narrative

The failure for heat was confirmed through functional testing, disassembly, and visual inspection.Through visual inspection, the bearing was found to be brinelled.The device was repaired and returned to stock after passing final inspection.

• Brand Name: LOANER CORE IMPACTION DRILL
• Type of Device: DRIVER, WIRE, AND BONE DRILL, MANUAL
• 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: 3851304
• MDR Text Key: 4461983
• Report Number: 0001811755-2014-02067
• Device Sequence Number: 1
• Product Code: DZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5400300000L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2013
• 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
• Patient Outcome(s): Other