MAUDE Adverse Event Report: K2M, INC. TAPERED DRIVER; SIZE 10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	201-90118
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot mpyu (1): manufacture date 11 november 2020, device returned 25 april 2022.Visual inspection confirmed tip wear and rotational tip deformation on the driver.Complaint history for the reported lot number was reviewed and no adverse trends were identified.Device history records were reviewed and no relevant manufacturing issues were identified.The root cause is most likely a combination of use of excessive torsional force as well as wear from frequent and consistent use.Lot ndgy (1): device returned 25 april 2022.Visual inspection confirmed tip wear and rotational tip deformation on the driver.Complaint history for the reported lot number was reviewed and no adverse trends were identified.The root cause is most likely a combination of use of excessive torsional force as well as wear from frequent and consistent use.Lot gdyv (2): manufacture date 05 december 2017, device returned 25 april 2022.Visual inspection confirmed tip wear and rotational tip deformation on both drivers.Complaint history for the reported lot number was reviewed and no adverse trends were identified.Device history records were reviewed and no relevant manufacturing issues were identified.The root cause is most likely a combination of use of excessive torsional force as well as wear from frequent and consistent use.Lot gdyv (1): manufacture date 05 december 2017, device returned 12 may 2022.The device was visually inspected and tip deformation was confirmed.Complaint history for the reported lot number was reviewed and no adverse trends were identified.The deformation is consistent with wear from normal use over the course of the device lifetime.Lot mpyu (1): manufacture date 11 november 2020, device returned 12 may 2022.The device was visually inspected and tip deformation was confirmed.Complaint history for the reported lot number was reviewed and no adverse trends were identified.The deformation is consistent with wear from normal use over the course of the device lifetime.
Event or Problem Description
This record is a consolidation of q2 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures six instances of intraoperative pyrenees tapered driver tip deformation.In two (of six) instances, the reported event was noted during inspection and there was no procedure associated with the event and no patient involvement.In four (of six) the associated procedure was completed successfully with no surgical delay.In all cases, there was no adverse consequence to a patient or user.

• Brand Name: TAPERED DRIVER; SIZE 10
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 15133038
• Report Number: 3004774118-2022-00292
• Device Sequence Number: 5399499
• Product Code: LXH
• UDI-Device Identifier: 10888857030183
• UDI-Public: 10888857030183
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 6
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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: 201-90118
• Device Catalogue Number: 201-90118
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/29/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown