MAUDE Adverse Event Report: K2M, INC. NON-TAPERED DRIVER, (SHORT); SIZE 20; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2112-90020
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a short capri non-tapered driver was observed to be stripped outside of the operating theater.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records were reviewed for the lot numbers provided, and no relevant manufacturing issues were identified.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.It was reported that the device stripped pre-operatively.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be conclusively established.However, as the device is seven years old, a potential root cause is normal wear due to age and use.
Event or Problem Description
It was reported that the tip of a short capri non-tapered driver was observed to be stripped outside of the operating theater.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.

• Brand Name: NON-TAPERED DRIVER, (SHORT); SIZE 20
• 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: 14077380
• Report Number: 3004774118-2022-00136
• Device Sequence Number: 5276928
• Product Code: LXH
• UDI-Device Identifier: 10888857033702
• UDI-Public: 10888857033702
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/19/2022

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: 2112-90020
• Device Catalogue Number: 2112-90020
• Device Lot Number: EAYJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2015
• 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