MAUDE Adverse Event Report: K2M, INC. ACCULIF GRAFT INSERTION CANNULA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	800305
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that outside the or an acculif graft insertion cannula was bent and unusable.There was no procedure associated with this event, therefore, no adverse consequences to any patients were seen.
Event or Problem Description
It was reported that outside the or an acculif graft insertion cannula was bent and unusable.There was no procedure associated with this event, therefore, no adverse consequences to any patients were seen.
Additional Manufacturer Narrative
The device was found to be deformed as reported.A sample graft insertion pusher cannot not pass through the graft cannula due to deformation.The device is no longer functional.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or adverse trends were identified.The reported lot number was manufactured in march of 2015 and is in use for over 7 years.The acculif surgical technique states the following: "instruments are provided by stryker spine and must be used to assure accurate implantation of the device.While rare, intraoperative fracture or breakage of instruments can occur.Instruments which have experienced extensive use or extensive force are more susceptible to fracture depending on the operative precaution, number of procedures, and disposal attention.Instruments must be examined for wear or damage prior to surgery.Instruments must be properly cleaned, maintained and lubricated as usually recommended for all surgical instruments".The plausible root cause of the reported event is normal wear and tear due to device age.Among consistent use of the instrument throughout its lifetime; cleaning, sterilization, handling may have also contributed to device deformation.H3 other text : status and location of the device is unknown.

• Brand Name: ACCULIF GRAFT INSERTION CANNULA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14626880
• Report Number: 0002530131-2022-00001
• Device Sequence Number: 14651083
• Product Code: LXH
• UDI-Device Identifier: 07613327105896
• UDI-Public: 07613327105896
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/18/2022

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: 800305
• Device Catalogue Number: 800305
• Device Lot Number: 12181410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2015
• 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