MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO DRILL MEDIUM STRAIGHT ATTACHMENT; UNIT, OPERATIVE DENTAL

Catalog Number 5100015250

Device Problem Electrical Power Problem (2925)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2015

Event Type  malfunction  

Event Description

It was reported that during use at the user facility the device had inconsistent speed.No adverse consequences or impact to patient, no delay, and no medical intervention reported.

Manufacturer Narrative

Upon follow up it was determined that the handpiece experienced a loss of power and not inconsistent speed as initially reported.The event for intermittent running was not confirmed as the product was not received for evaluation.Report 0001811755-2015-04049 ((b)(4)) was filed in error.Device was not returned to stryker instruments for evaluation.

Event Description

It was reported that during use at the user facility the handpiece being used with the attachment would lose power during use.No adverse consequences or impact to patient, no delay, and no medical intervention reported.

• Brand Name: MICRO DRILL MEDIUM STRAIGHT ATTACHMENT
• Type of Device: UNIT, OPERATIVE DENTAL
• 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: 5211848
• MDR Text Key: 30804381
• Report Number: 0001811755-2015-04049
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5100015250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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