MAUDE Adverse Event Report: DEPUY MITEK LLC US PRC AWL / TAP; BONE AWL

Catalog Number	222273
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : the complaint device was received and evaluated.A visual inspection was performed to determine if the device had any gross visual defects that may contribute to the reported failure.There appears to be a slight bend towards the middle of the shaft.Therefore, this complaint can be confirmed.The information provided is not sufficient to determine a definitive root cause.However, it is possible that excessive force could have been applied to the device during the case, hence causing deformation to the shaft.Furthermore, a manufacturing record evaluation was performed for the finished device [1511001] number, and no non-conformance were identified.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 the tip of the healix transtend awl/tap is bent.Another device was used to complete the procedure.No patient consequences or surgical delay reported.

• Brand Name: PRC AWL / TAP
• Common Device Name: BONE AWL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9569619
• Report Number: 1221934-2020-00110
• Device Sequence Number: 18908695
• Product Code: LXH
• UDI-Device Identifier: 10886705008186
• UDI-Public: 10886705008186
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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 Catalogue Number: 222273
• Device Lot Number: 1511001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/09/2020
• Patient Sequence Number: 1