MAUDE Adverse Event Report: DEPUY MITEK LLC US CURVED OSTEOTOME; ORTHOPAEDIC OSTEOTOME

Model Number 285270

Device Problem Unintended Movement (3026)

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

Event Date 03/02/2023

Event Type  malfunction  

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).The expiration date is 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 Description

It was reported by a healthcare professional in australia that during an unknown procedure on (b)(6) 2023, it was observed that the handle on the curved osteotome device appeared loose.It was unknown how the procedure was completed.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 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: investigation summary: the complaint device has not been returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photo, the handle appeared to be heavily used, and the plate appeared to have separated from the handle.Therefore, this complaint can be confirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.The photo does not provide enough evidence to determine root cause.Physical evaluation should provide more information to discern a possible root cause.Lot number on the device indicates this device is 13 years old.The possible root cause for the reported failure can be attributed to the age of the device and rough use; since this device is reusable, the continuous use and sterilization processes can contribute to a progressive degradation.However, this cannot be conclusively determined.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.

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.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
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> 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 in the handle.Also, scratches could be identified on the device.Neither the handle nor the shaft shows any anomality.Manual movement of the shaft showed that there was slight movement of the shaft separated from the handle.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.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.The manufactured date of this device is 2010 and hence indicates this device is 13 years old.Based on the visual inspection results, this complaint can be confirmed.The possible root cause for the condition of the device could be related to heavily use; moreover, drop of the unit, mishandling or procedural variables that could cause the loose condition of the device shaft.A possible root cause for the wear condition could be related to fair wear and tear due to age and use.However, it cannot be conclusively affirmed.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.

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.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.

• Brand Name: CURVED OSTEOTOME
• Type of Device: ORTHOPAEDIC OSTEOTOME
• 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: 16574456
• MDR Text Key: 312215521
• Report Number: 1221934-2023-01276
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705018000
• UDI-Public: 10886705018000
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• 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
• Device Operator: Health Professional
• Device Model Number: 285270
• Device Catalogue Number: 285270
• Device Lot Number: 10D2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 03/21/2023; 08/21/2023; 08/28/2023
• Supplement Dates FDA Received: 03/22/2023; 08/22/2023; 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1