MAUDE Adverse Event Report: K2M, INC. LOCKING SCREW INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2901-90098
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
Event or Problem Description
This report captures four instances of intraoperative everest locking screw inserter tip deformation.In all cases, the associated procedure was completed successfully with no surgical delay and no adverse consequence to a patient or user.
Additional Manufacturer Narrative
Lot ndyb (1): device returned 26 may 2022.The investigation is still in process; we will communicate our findings in a follow-up report.Lot achfn028 (1): device returned 12 may 2022.The investigation is still in process; we will communicate our findings in a follow-up report.Lot fdrk002 (1): manufacture date 03 january 2018, device returned 28 april 2022 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 returned device was visually inspected; wear and tear was observed along the entire device.A small deformation on the inner shaft and buildup of debris on the threading were noted.The most likely root cause of the reported event is normal device wear.The instrument has been in the field for over four years; consistent use of the instrument throughout its lifetime may cause fatigue and lead to the reported failure.Lot hfjf (1): manufacture date 26 september 2018, device returned 28 april 2022 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 device was visually inspected and deformation seen on the threading and along the tip.The most likely root cause of the reported event is normal device wear.Deformation is the result of repeated, consistent use of the instrument throughout its lifetime which gradually weakens the material integrity at the tip.
Additional Manufacturer Narrative
Lot ndyb (1): manufacture date 10 february 2021, device returned 26 may 2022.Lot fdrk002 (1): manufacture date 03 january 2018, device returned 12 may 2022.Lot fdrk002 (1): manufacture date 03 january 2018, device returned 28 april 2022.Lot hfjf (1): manufacture date 26 september 2018, device returned 28 april 2022.
Event or Problem Description
This report captures (b)(4) instances of intraoperative everest locking screw inserter tip deformation.In all cases, the associated procedure was completed successfully with no surgical delay and no adverse consequence to a patient or user.

• Brand Name: LOCKING SCREW INSERTER
• 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: 15131915
• Report Number: 3004774118-2022-00290
• Device Sequence Number: 20250561
• Product Code: LXH
• UDI-Device Identifier: 10888857040564
• UDI-Public: 10888857040564
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 4
• 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,Followup
• Report Date (Section B): 10/25/2022

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: 2901-90098
• Device Catalogue Number: 2901-90098
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 10/01/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 10/25/2022
• 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