MAUDE Adverse Event Report: DEPUY MITEK LLC US 23MM HEX DRIVER W/TEARDROP HANDLE -NS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	270127
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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.H10 additional narrative: e3: reporter is a j&j sales representative.E1: the reporter¿s complete facility address was not provided.D4, h4: the lot number was unknown; therefore, the expiration date and device manufacture date were unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(6).
Event or Problem Description
It was reported by the sales rep that on an unknown date, it was observed that the tip of the hex driver with teardrop handle 23mm device was bent.The device was not used in a procedure as it was found while checking an instrument tray.The event was not related to surgery.There was no patient involvement.There were no adverse patient consequences 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 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.H10 additional narrative: investigation summary: the device associated with this report was returned to depuy synthes mitek for evaluation.Upon visual inspection revealed that the 23mm hex driver w/teardrop handle-ns has wear use.It could be observed the tip of the device with a slight bent condition.Neither the handle nor the shaft shows any anomality.The overall complaint was confirmed as the observed condition of the 23mm hex driver w/teardrop handle -ns would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced 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.As per ifu, 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, and it has been determined that no corrective and/or preventative action is required.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: 23MM HEX DRIVER W/TEARDROP HANDLE -NS
• 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: 18741720
• Report Number: 1221934-2024-00518
• Device Sequence Number: 20641501
• Product Code: LXH
• UDI-Device Identifier: 10886705014033
• UDI-Public: 10886705014033
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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: 270127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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