MAUDE Adverse Event Report: DEPUY MITEK LLC US LATARJET TOP HAT SCREW DRIVER; TOP HAT SCREWDRIVER

Model Number	285295
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: background: the mdr department is complaining about the instruments in this set, saying the bolts that hold the driver shafts in the handles can come loose or hold debris under them.Investigation summary: the latarjet top hat screw driver (part #: 285295, lot #: 13j01) was received and evaluated at us cq.Upon visual inspection, there was rust on etch of the device.Thus, the reported complaint can be confirmed.The possible root cause could be attributed to fair wear and tear from the repeated use and sterilization cycles.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent to which this complaint is observed in the field a manufacturing record evaluation was performed for the finished device lot number (13j01), and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
It was reported from the affiliate that the latarjet top hat screw driver device bolts that held the driver shaft in the handles came loose and held debris under them.During an in-house engineering evaluation, it was determined that the device had rust on the etch of the device.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the procedure or whether a like device was available for use.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: LATARJET TOP HAT SCREW DRIVER
• Common Device Name: TOP HAT SCREWDRIVER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12191665
• Report Number: 1221934-2021-02213
• Device Sequence Number: 3590358
• Product Code: LXH
• UDI-Device Identifier: 10886705018086
• UDI-Public: 10886705018086
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 285295
• Device Catalogue Number: 285295
• Device Lot Number: 13J01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1