MAUDE Adverse Event Report: DEPUY MITEK LLC US NG HEALIX ALL-IN-ONE AWL; BONE AWL

Model Number 222314

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problems Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Udi: (b)(4).

Event Description

It was reported by sales rep via complaint submission tool that while dr.(b)(6) was performing a rcr he noticed arthroscopically that the tip of the 4.5 awl was bent.We opened another peel packed 4.5 awl and were able to continue with the procedure.The patient was not affected and the procedure was delayed for two minutes.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).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
=
> according to the information provided, it was reported by sales rep via complaint submission tool that while dr.Purcell was performing a rcr he noticed arthroscopically that the tip of the 4.5 awl was bent.The complaint device was received and evaluated.Visual observations confirm that the distal tip of the device is slightly bent.The complaint can be confirmed.The possible root cause for the reported failure can be attributed when the device might have been dropped or device was tapped at an off angle or hit the bone accidentally at an off angle however, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot number:2001001, and no non-conformances 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).

• Brand Name: NG HEALIX ALL-IN-ONE AWL
• Type of Device: BONE AWL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10820202
• MDR Text Key: 215987614
• Report Number: 1221934-2020-03433
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705022458
• UDI-Public: 10886705022458
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

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
• Device Operator: Health Professional
• Device Model Number: 222314
• Device Catalogue Number: 222314
• Device Lot Number: 2001001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 12/08/2020
• Patient Sequence Number: 1