MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5/6.5 HEALIX ADVANCE AW; BONE AWL

Model Number 222315

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: udi: (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.

Event Description

It was reported by sales rep that during a shoulder scope on (b)(6) 2022, it was observed that the handle on the 5.5/6.5 healix advance awl device was loose and rotating in the surgeons hand while using it.According to the report, the surgeon was able to insert the device all the way to laser line to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

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 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: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

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 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.Investigation summary the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observation confirms the sharp tip at the distal end appears to be flattened, confirming this failure.Also, the distal part was dull to the touch and found with scratches.The healix had wear marks.Finally, the laser line was slighly faded.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.Based on the results, the complaint cannot be confirmed.The possible root cause for the tip damage could be related when the device might have been dropped or device was tapped against a hard surface accidentally.It is determined that the reusable instrument is worn from repeated use and servicing, this failure can be attributed to normal field wear.However, it cannot be conclusively affirmed.As per ifu, the precautions for this type of device consist 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: 5.5/6.5 HEALIX ADVANCE AW
• Type of Device: BONE AWL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 13258418
• MDR Text Key: 284447635
• Report Number: 1221934-2022-00189
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705022465
• UDI-Public: 10886705022465
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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: 222315
• Device Catalogue Number: 222315
• Device Lot Number: 1205003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 03/03/2022; 03/11/2022; 03/11/2022
• Supplement Dates FDA Received: 03/04/2022; 03/11/2022; 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1