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

Catalog Number 234-200-200

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tip broke inside the patient bone; however, the tip was removed from the patient and there was no surgical intervention/harm to patient.

Manufacturer Narrative

The reported device was not received for investigation; therefore the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: design: -cable design is weak.-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.-affected heat zone from weld too large, cable weakened.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, -hard bone, -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 product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the tip broke inside the patient bone; however, the tip was removed from the patient and there was no surgical intervention/harm to patient.

• 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: kimberly lynch ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 4974180
• MDR Text Key: 23681485
• Report Number: 0002936485-2015-00710
• 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: Other
• Type of Report: Followup
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 56886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• 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