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

Catalog Number 234-200-200

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 08/05/2014

Event Type  malfunction  

Event Description

It was reported that the tip detached into the joint and was successfully retrieved after a 10 minute surgical delay.

Manufacturer Narrative

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

Manufacturer Narrative

The unit was not returned and the failure mode was not confirmed.Based on the information provided by the sales rep, this was the first time the surgeon had used the microfx drill system.The sales rep told the surgeon to make sure that the guide was completely flush against the bone.However, he noticed that the surgeon was not holding the guide completely flush with the bone, so it skived under the drill guide and broke off.This product has been evaluated in verification testing to withstand many cycles in a hard bone analogue without failure to greater than 20 holes; it is also possible that in this instance the bone was even harder than this test analogue and represents a small majority of patient anatomy across the spectrum of use.However, based on the available information and the relative inexperience of the surgeon with the microfx drill system and the fact that use of this product is very technique oriented, the most likely root cause is user error.In sum, the unit was not returned and the failure mode was not confirmed.

Event Description

It was reported that the tip detached into the joint and was successfully retrieved after a 10 minute surgical delay.

• 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: 4047942
• MDR Text Key: 15122843
• Report Number: 0002936485-2014-00637
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/05/2014

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: 49371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2014
• Initial Date FDA Received: 08/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2014
• 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