MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5/6.5 HEALIX ADVANCE AWL; BONE AWL

Catalog Number	222315
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and inspected.The sharp tip at the distal end appears to be flattened and not broken, confirming this failure.Historically, this type of failure has been observed when the device might have been dropped or device was tapped at an off angle or hit the bone accidentally at an off angle.It cannot be determined at what point in time this failure occurred.Further, a review into the mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point in time, no corrective action is required and no further action is warranted.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.The lot number is currently unavailable.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, the awl device was used once during surgery with no problem, the second one was used and the surgeon noted it was dull.It was further reported that just prior to the third use the nurse noticed that the tip was broken off.It was reported that the surgeon continued to use it three more times during surgery and it was just more difficult to enter the bone.The surgeon did not know when or how it broke.It was reported that the surgeon didn't have the tip and have no suspicion that it may in the patient.It was reported that it was possible that it was already broken and not noticed.It was reported that the surgeon continued using the broken awl with no problem or pt consequences.It was not reported if there were any delays in the surgical procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 5.5/6.5 HEALIX ADVANCE AWL
• Common Device Name: BONE AWL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7873024
• Report Number: 1221934-2018-51501
• Device Sequence Number: 16659373
• Product Code: LXH
• UDI-Device Identifier: 10886705022465
• UDI-Public: 10886705022465
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2016

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: 222315
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2016
• Initial Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1