MAUDE Adverse Event Report: DEPUY MITEK HEALIX ADVANCE AWL, 5.5/6.5 MM, EA; BONE AWL

Catalog Number	222315
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2015
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, 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.A batch record review has been conducted for this lot and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed unrelated complaints for this lot of devices that were released to distribution.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).This report is being filed from the remetrex 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 from the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that the awl device was bent, broke and the tip buckled after pushing into the bone.It was reported that there was a two minute delay in the surgical procedure and a spare device was available for use.There was patient involvement.There were no 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.

• Brand Name: HEALIX ADVANCE AWL, 5.5/6.5 MM, EA
• Common Device Name: BONE AWL
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7756613
• Report Number: 1221934-2018-53522
• Device Sequence Number: 19297926
• Product Code: LXH
• UDI-Device Identifier: 10886705022465
• UDI-Public: 10886705022465
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/11/2015

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
• Device Lot Number: 1211001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2015
• Initial Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1