MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE MICROFX OCD UNIVERSAL DRILL; REAMER

Catalog Number 234-200-200

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

It was reported that a doctor was using the microfx drill in the hip with a 90 degree curve guide.In his first attempt to drill a hole, the drill snapped where the bendable portion attaches to the rigid shaft.The doctor drilled at a controlled speed and had complete control of the guide with zero movement.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that a doctor was using the microfx drill in the hip with a 90 degree curve guide.In his first attempt to drill a hole the drill snapped where the bendable portion attaches to the rigid shaft.The doctor drilled at a controlled speed and had complete control of the guide with zero movement.

Manufacturer Narrative

The product was returned for investigation.The reported failure mode was confirmed.The drill is broken at the proximal end of the cable where the cable meets the rigid shaft of the drill.The cable appears to be unraveling near the drill tip and the drill tip shows wear along the cutting edges.Based on the event description and additional information provided, hard bone as well as user technique leading to skiving are considered the primary root causes.In sum, the product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.

• Brand Name: MICROFX OCD UNIVERSAL DRILL
• Type of Device: REAMER
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: thomas shafer ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 3613971
• MDR Text Key: 4092929
• Report Number: 0002936485-2014-00059
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 234-200-200
• Device Lot Number: 43999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1