MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE FULLFLUTE REAM 8.5MM *EA; CANNULATED SURGICAL DRILL

Model Number 219555

Device Problems Dull, Blunt (2407); Illegible Information (4050)

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

Event Date 08/19/2022

Event Type  malfunction  

Event Description

It was reported by the sales rep that the restore fullflute ream 8.5mm device was had illegible etch.During an in-house engineering evaluation, it was determined that the device would not cut/dull.There was no procedure involved.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.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.Reporter is a j&j sales representative.The device serial/lot number and device manufacture date were unknown.Udi: (b)(4) incomplete.The lot number was unknown.The product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Visual observations revealed marks of wear on the device and damage was observed in the distal part.The distal part showed that the device had been heavily used and it was found dull.Also, the laser marks were faded; besides the laser line was not visible.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.It is determined that the reusable instrument is worn from repeated use and servicing, this failure can be attributed to normal field wear.The possible root cause of the damage in the tip can be attributed when the device being dropped/ mishandled on hard surface causing the weld to fail.Besides, possibility of mishandling, we cannot discern a root cause for this failure mode.As per ifu, inspect the instruments before use for integrity and compatibility in order to ensure proper functionality and safety.Place the instrument in the appropriate location within the sterilization tray.During the cleaning process, inspect the instruments after each cleaning cycle to ensure proper functionality function and safety.If you suspect a problem, set aside the instrument for repair.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.

• Type of Device: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15619000
• MDR Text Key: 302578398
• Report Number: 1221934-2022-03138
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886705006762
• UDI-Public: 10886705006762
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 219555
• Device Catalogue Number: 219555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Date Manufacturer Received: 10/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1