MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX ADVANCE 4.0MM DRILL BIT; SURGICAL HAND DRILL

Model Number	222326
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported by the sales rep via phone that two 4.0 mm healix drill were found dull during inspection.No procedure or patient was involved.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary = > the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Further, no lot numbers were supplied which precludes conducting a dhr 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.

• Brand Name: HEALIX ADVANCE 4.0MM DRILL BIT
• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10343479
• Report Number: 1221934-2020-01955
• Device Sequence Number: 2186352
• Product Code: LXH
• UDI-Device Identifier: 10886705021802
• UDI-Public: 10886705021802
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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 Model Number: 222326
• Device Catalogue Number: 222326
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1