MAUDE Adverse Event Report: CAYENNE MEDICAL QUATTRO 2.4 MM HARD BONE DRILL

Model Number N/A

Device Problems Fracture (1260); Nonstandard Device (1420)

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

Event Date 10/30/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.And the drill was broken at the base.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Investigation results concluded that the reported event was due to either bending the drill in the drill guide while drilling, drill guide shifting, or applying a lot of side pressure on drill and/or drill guide while drilling.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during an orthoscopic labral repair surgery, the drill broke at the base of the fluted portion.The surgeon then proceeded to switch the surgical technique to an "open surgery", in order to remove the drill bit from the patient's shoulder.Fractured pieces was removed with no issues.

• Brand Name: QUATTRO 2.4 MM HARD BONE DRILL
• Type of Device: DRILL
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; 101; scottsdale AZ 85260
• Manufacturer (Section G): LSO; 830 challenger st; brea CA 92821
• Manufacturer Contact: shima hashemian ; 16597 n 92nd street; 101; scottsdale, AZ 85260 ; 4805023661
• MDR Report Key: 8186883
• MDR Text Key: 131132851
• Report Number: 3006108336-2018-00030
• Device Sequence Number: 0
• Product Code: NBH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CM-9324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2013
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2013
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention