MAUDE Adverse Event Report: DEPUY MITEK DRILL BIT (STABILIZATION); ANCHOR INSTRUMENTS

Catalog Number 211033

Device Problem Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2015

Event Type  malfunction  

Event Description

The sales rep reported that when drilling with the customer's lupine stabilizing drill bit during a shoulder repair that metal shavings were created in the patient's joint space.The sales rep reported all of these were removed using the shaver.The surgeon had finished with the drill bit at that time and completed the procedure with no patient consequences or delays.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek; however, it is not known if it will be received within the 30 day reporting requirement, therefore, depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.Awaiting return.

Manufacturer Narrative

The complaint device is not being returned, therefore unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

Event Description

The sales rep reported that when drilling with the customer's lupine stabilizing drill bit during a shoulder repair that metal shavings were created in the patients joint space.The sales rep reported all of these were removed using the shaver.The surgeon had finished with the drill bit at that time and completed the procedure with no patient consequences or delays.

• Brand Name: DRILL BIT (STABILIZATION)
• Type of Device: ANCHOR INSTRUMENTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: bahaa nashed ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4533656
• MDR Text Key: 5544297
• Report Number: 1221934-2015-00623
• Device Sequence Number: 1
• Product Code: HTW
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211033
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2015
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1