MAUDE Adverse Event Report: K2M, INC. GRAFT CONTAINMENT RAMP, W/ADAPTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	3201-90293
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an aleutian lateral inserter inner shaft was not threading properly onto the implant and an aleutian lateral graft containment ramp showed signs of wear intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with a 5 minute delay to surgery by using the complaint devices.This report captures the graft ramp.
Event or Problem Description
It was reported that an aleutian lateral inserter inner shaft was not threading properly onto the implant and an aleutian lateral graft containment ramp showed signs of wear intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully with a 5 minute delay to surgery by using the complaint devices.This report captures the graft ramp.
Additional Manufacturer Narrative
Visual inspection: the device was inspected.It was observed that the device had significant wear throughout its main body and the device was slightly deformed as well.Device history records were reviewed for this lot, in a lot size of 33 units.Review of the records revealed a relevant non-conformance.Complaint history records were reviewed for this lot, similar complaints were identified.According to the surgical technique guide: placement of bone graft: when used as a lumbar intervertebral body fusion device, the implants are indicated for spinal fusion procedures to be used with autograft and/or allogenic bone graft in skeletally mature patients.According to the device history review, it was observed that the instrument has been out in the field for more than 4 years.Factors such as consistent use of the instrument throughout its lifetime may cause fatigue on the instrument, leading to the reported failure mode.

• Brand Name: GRAFT CONTAINMENT RAMP, W/ADAPTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11761185
• Report Number: 3004774118-2021-00133
• Device Sequence Number: 11853849
• Product Code: LXH
• UDI-Device Identifier: 10888857059313
• UDI-Public: 10888857059313
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/30/2021

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 Catalogue Number: 3201-90293
• Device Lot Number: FJUM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 77