MAUDE Adverse Event Report: DEPUY MITEK LLC US TRACKER CUTTING BLOCK *EA; GRAFT PREPARATION STATION

Model Number	219452
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This is report 2 of 2 for (b)(4).It was reported by the sales rep that during an unknown procedure on (b)(6) 2022, it was observed that the tracker cutting block total and the tracker cut block w/pivot total were bent and not matching anymore.Another like devices were used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.This complaint involves two (2) devices.
Additional Manufacturer Narrative
Additional narrative: udi: (b)(4).The lot number was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were unknown.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.No lot numbers were supplied which precludes conducting a dhr review or a lot of specific search in the complaints handling system.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Common Device Name: GRAFT PREPARATION STATION
• 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: 14337501
• Report Number: 1221934-2022-01355
• Device Sequence Number: 15007202
• Product Code: LXH
• UDI-Device Identifier: 10886705006540
• UDI-Public: 10886705006540
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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

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: 219452
• Device Catalogue Number: 219452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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