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

Catalog Number 234-200-200

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 09/17/2014

Event Type  malfunction  

Event Description

It was reported that the tip of the unit broke off and was retrieved successfully.

Manufacturer Narrative

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

Manufacturer Narrative

This product has been evaluated in verification testing to withstand many cycles in a hard bone analogue of 50/30 pcf 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.The use of this product is also very technique oriented and there are several user related issues that can occur that can lead cause the drill to skive underneath the drill guide exit which would lead to microfx drill tip breakage: not enough force applied to guide to keep against bone during drill insertion: if the guide is not held firmly against the patient bone during use, the drill has the potential to push the guide up and skive underneath the end of the guide leading to drill breakage.Holding the guide at an angle (guide exit not flush against patient bone): if the guide exit is held at an angle to the patient bone it is likely that the drill tip may skive underneath the guide teeth.The surgeon not holding both the drill and the guide during drill insertion: if the surgeon is not holding both the guide and drill it is possible that the surgeon may not realized that the drill is in a situation where the tip may skive.Running the drill in reverse during drill insertion: the coils of the flexible section of the drill are designed to only be drilled in the forward direction while drilling into the patient bone to create a microfracture hole.All of the above instances can lead to the surgeon skived underneath the drill and the drill tip breaking.It is suggested that the following steps are followed to alleviate drill breakage: the surgeon should hold both the drill and the guide.The surgeon should hold the guide firmly against the patient bone during drill use.The surgeon should hold the guide flush against the patient bone.If the surgeon skives, he/she should check the drill before continuing surgery.The surgeon should always drill in forward.The product was not returned for investigation, therefore the reported failure mode could not be confirmed.The failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the tip of the unit broke off and was retrieved successfully.

• 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: 4145257
• MDR Text Key: 16450656
• Report Number: 0002936485-2014-00792
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/17/2014

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: 53676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 10/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2015
• 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
• Patient Age: 47 YR
• Patient Weight: 64