MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX KNOTLESS AWL, 3.4MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	219495
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that during an arthroscopic shoulder rotator cuff repair procedure on (b)(6) 2023, it was observed that the shaft on the healix knotless awl, 3.4mm device was loose and spun inside the handle when inserted into the hard bone.It was unknown if and how the procedure was completed.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: udi: (b)(4).D4: the expiration date is currently unavailable.E3: reporter is a j&j sales representative.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.
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 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.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.H10 additional narrative: investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Upon visual inspection the device showed wear use.It could be observed the tip of the device with a bent condition.Also, it could be identified the etch marks slightly faded.Neither the handle nor the shaft shows any anomality.Manual movement of the shaft showed that there was no movement of the shaft separated from the handle.A manufacturing record evaluation was performed for the finished device and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the visual inspection results, this complaint cannot be confirmed.A possible root cause for the issue experienced by the customer cannot be determined.The possible root cause for the condition of the device tip could be related to heavily use; moreover, drop of the unit, mishandling or procedural variables that could cause the bent condition of the device tip.Since this device is reusable, the continuous use and sterilization process can cause worn condition.However, it cannot be conclusively affirmed.As per the instructions for use, inspect for damage prior to use.Replace a damaged, worn or bent instrument.Do not attempt to straighten, sharpen or repair.Do not use a depuy mitek reusable instrument for any purpose other than its intended use as that may result in damage to the instrument.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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: a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the shaft appear to be in a normal used condition, the shaft shows the device information, these information was verified and it is correct.With the photo provided is not possible to determine if the shaft has a damage.A manufacturing record evaluation was performed for the finished device 1904001, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the visual inspection of the photo, this complaint cannot be confirmed.The device is required for testing, the photo provided does not contain enough evidence to determine why the customer experienced the failure, hands on analysis should provide the required evidence to provide a root cause.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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.

• Brand Name: HEALIX KNOTLESS AWL, 3.4MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 17399518
• Report Number: 1221934-2023-02812
• Device Sequence Number: 17644328
• Product Code: LXH
• UDI-Device Identifier: 10886705022373
• UDI-Public: 10886705022373
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,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 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: 07/07/2023
• Supplement Date Received by Manufacturer: 08/01/2023; 08/09/2023; 08/20/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/02/2023; 08/10/2023; 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown