MAUDE Adverse Event Report: K2M, INC. CAYMAN UNITED PLATE INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7902-90033
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that outside the operating room, the cayman united plate inserter won't release from plate when loosened.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
Additional Manufacturer Narrative
Visual, dimensional and functional analysis could not be performed as the device was not returned.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained.Since the issue was noticed during inspection, a conclusive cause of the problem could not be identified.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker.If devices and / or additional information become available, this investigation will be reopened.
Event or Problem Description
It was reported that outside the or, the cayman united plate inserter won't release from plate when loosened.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.

• Brand Name: CAYMAN UNITED PLATE 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: 12558384
• Report Number: 3004774118-2021-00294
• Device Sequence Number: 19979485
• Product Code: LXH
• UDI-Device Identifier: 10888857383708
• UDI-Public: 10888857383708
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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: 7902-90033
• Device Catalogue Number: 7902-90033
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 01/11/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown