MAUDE Adverse Event Report: DEPUY MITEK LLC US FULLY FLUTED REAMER; CANNULATED SURGICAL DRILL

Model Number	219349
Medical Device Problem Codes	Degraded (1153); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a healthcare professional in colombia that the tip on the fully fluted reamer device was damaged.During in-house engineering evaluation, it was determined that the tip was dull.There was no procedure nor patient involvement 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.Investigation summary: a photo was returned to depuy synthese mitek for evaluation.The depuy synthese mitek team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the tip is dull due to the use.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 synthese mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the investigation findings, the reported complaint can be confirmed.The possible root cause for the reported issue can be attributed to the constant and hard use of the device.Since this is a reusable device, the constant manipulation between surgeries and sterilization process can lead to a dull edges.As per ifu: end of useful instrument life is generally determined by wear or damage from handling or surgical use.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthese 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.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 wil be filed as appropriate.H10 additional narrative: investigation summary the complaint device was received and evaluated.Upon visual inspection, it could be observed that the tip is dull due to the use.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.Based on the investigation findings, the reported complaint can be confirmed.The possible root cause for the reported issue can be attributed to the constant and hard use of the device.Since this is a reusable device, the constant manipulation between surgeries and sterilization process can lead to a dull edges.As per ifu 109284: end of useful instrument life is generally determined by wear or damage from handling or surgical use.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.

• Brand Name: FULLY FLUTED REAMER
• Common Device Name: CANNULATED SURGICAL DRILL
• 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: 17023033
• Report Number: 1221934-2023-02181
• Device Sequence Number: 20700431
• Product Code: HTO
• UDI-Device Identifier: 10886705005925
• UDI-Public: 10886705005925
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other,Foreign,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 Model Number: 219349
• Device Catalogue Number: 219349
• Device Lot Number: 1605001
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 07/20/2023; 07/29/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/11/2023; 07/25/2023; 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown