MAUDE Adverse Event Report: DEPUY MITEK LLC US GII DRBIT ARTHRO 2.4MM *EA; SURGICAL HAND DRILL

Catalog Number	211502
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.Investigation summary: the complaint device was received and evaluated.Visual observation indicates the device is in worn condition possibly from repeated heavy use.The drill bit has striations from heavy use.This complaint can be confirmed and the failure could be attributed to normal field wear.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 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.(b)(4) ¿ incomplete.Depuy mitek has been informed that the lot number is not available.
Event or Problem Description
It was reported via phone by the sales rep, that during a biceps procedure, the customer's gii drill bit would not engage in the bone.They swapped the device with another like device from the other set to complete the procedure.There were no patient consequences or delays.The device is being returned.

• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7405970
• Report Number: 1221934-2018-50425
• Device Sequence Number: 13769045
• Product Code: HTW
• UDI-Device Identifier: 10886705001743
• UDI-Public: 10886705001743
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 211502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Initial Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1