MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX ADVANCE AWL; BONE AWL

Model Number	222314
Medical Device Problem Codes	Material Deformation (2976); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This is report 2 of 2 for (b)(4).It was reported by the sales rep that during a rotator cuff repair procedure on an unknown date, it was observed that the laser lines on the 4.5 healix advance awl device were very hard to see.During in-house engineering evaluation, it was determined that the sharp tip at the distal end on the device appeared to be slighly flattened.The procedure was completed successfully.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi:(b)(4).Initial reporter occupation: reporter is a j&j sales representative.Device manufacture date: the expiration date and device manufacture date are currently unavailable.Investigation summarythe product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received provided by customer.Visual observation revealed that the sharp tip at the distal end appears to be slightly flattened.Also, scratches were found near the tip.Finally, the laser line was not visible for the correct insertion depth.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.Based on the condition of the device, this complaint can be confirmed.It is determined that the reusable instrument is worn from repeated use and servicing, this failure can be attributed to normal field wear.For the tip condition could be related when the device might have been dropped or device was tapped against a hard surface accidentally.However, it cannot be conclusively affirmed.As per ifu: the precautions for this type of device consist of to inspect the condition of the device prior to use.This device can damage, worn or bent; therefore, when this occurs it need to replace.The instrument life is generally determined by the wear or damaged from handling or surgical use.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: 4.5 HEALIX ADVANCE AWL
• Common Device Name: BONE AWL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15001957
• Report Number: 1221934-2022-02134
• Device Sequence Number: 1597385
• Product Code: LXH
• UDI-Device Identifier: 10886705022458
• UDI-Public: 10886705022458
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 222314
• Device Catalogue Number: 222314
• Device Lot Number: 1207001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown