MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX KNOTLESS AWL 3.4MM; BONE AWL

Model Number	219495
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: according to the information provided, it was reported that during a rotator cuff repair that the 4.5 healix advance awl, the 4.5 healix advance cortical awl-tap and the healix knotless awl, 3.4 mm are faded.This complaint device was received and visually inspected.Visual observation revealed that the laser lines were completely faded.Visual observation showed marks that it was worn, indicate possible heavy use.Finally, the sharp tip at the distal end appears to be flattened.Since it is a reusable device, the possible root cause could be related to the autoclave process negatively affecting the laser lines.Repeated use/ sterilization cycles further contribute to this failure mode.This failure can be attributed to normal field wear.For the damage in the tip can be attribute this type of failure when the device might have been dropped or device was tapped against a hard surface on several occasions.However, it cannot be conclusively affirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during a rotator cuff repair that the 4.5 healix advance awl, the 4.5 healix advance cortical awl-tap and the healix knotless awl, 3.4 mm are faded.Another device was used to complete the procedure.No patient consequences or surgical delay reported.The device(s) is/are available to be returned for evaluation.

• Brand Name: HEALIX KNOTLESS AWL 3.4MM
• Common Device Name: BONE AWL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10462618
• Report Number: 1221934-2020-02316
• Device Sequence Number: 2344276
• Product Code: LXH
• UDI-Device Identifier: 10886705022373
• UDI-Public: 10886705022373
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2020

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: 219495
• Device Catalogue Number: 219495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2020
• Initial Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1