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

Catalog Number 234-200-200

Device Problem Component Falling (1105)

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

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported tip broke, while attempting to remove the tip fell into hip joint space.Tip was recovered and procedure was completed successfully.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: tip broke.Probable root cause: design: drill too dull or dulls quickly, inefficient flute design, requires excessive force to advance; drill not in alignment with guide; drill allowed to extend too far out of guide.Process: drill manufactured out of specification; drill guide manufactured out of specification.Application: excessive axial force on drill; run drill in reverse; reuse/resterilization of single-use device, or use of a single drill on multiple defects; guide is translated and/or rotated during drilling; drill not in alignment with guide; user does not use snap cap, drills too deep; drill is started/stopped while in bone (technique guide instructs to run continuously during drilling).The device manufacturer date is not known at this time.(b)(4).

Event Description

It was reported tip broke, while attempting to remove the tip fell into hip joint space.Tip was recovered and procedure was completed successfully.

• Brand Name: MICROFX OCD UNIVERSAL DRILL
• Type of Device: BIT, DRILL
• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 5604851
• MDR Text Key: 44192502
• Report Number: 0002936485-2016-00399
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 234-200-200
• Device Lot Number: 62075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 47 YR