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

Model Number	219495
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
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).Reporter is a j&j sales representative.The expiration date and device manufacture date are currently unavailable.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 or Problem Description
It was reported by the sales rep that during a shoulder scope procedure on 8/29/2022, it was observed that the healix knotless awl, 3.4mm device was loose while malleting.Another like device was used to complete the procedure.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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observation revealed that the sharp tip at the distal end appears to be slightly flattened.Also, the distal part of the handle found with scratches and a metal part near the handle was broken.The healix had marks of heavily use.Based on the condition reported , this complaint cannot be confirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.The possible root cause could be related when the tip 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, 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 mitkek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• 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
• 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: 15396259
• Report Number: 1221934-2022-02811
• Device Sequence Number: 6124377
• Product Code: LXH
• UDI-Device Identifier: 10886705022373
• UDI-Public: 10886705022373
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,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
• Operator of Device: Health Professional
• Device Model Number: 219495
• Device Catalogue Number: 219495
• Device Lot Number: 1904001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 09/15/2022; 10/25/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 09/16/2022; 10/26/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown