MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE ACORNREAM 9.5MM THIN *EA; CANNULATED SURGICAL DRILL

Model Number	219550
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that the restore acornream 9.5mm thin *ea device had illegible etch (faded).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.
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.Additional narrative: reporter is a j&j sales representative.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.According to the information provided, it was reported that the numbers of the following instruments can no longer be read, and they are really dull (not sharp).Lot numbers are not visible.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 is 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 instructions for use (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.

• Common Device Name: 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: 15619332
• Report Number: 1221934-2022-03139
• Device Sequence Number: 8008037
• Product Code: HTO
• UDI-Device Identifier: 10886705006717
• UDI-Public: 10886705006717
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 219550
• Device Catalogue Number: 219550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2022
• Initial Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown