MAUDE Adverse Event Report: K2M, INC. LATERAL INSERTER INNER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	3201-90270
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 inserter inner shaft.
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that the threading at the distal tip was damaged.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The ravine lateral access system featuring aleutian lateral & cascadia lateral interbody systems surgical technique was reviewed and the following relevant information was identified: interbody insertion for implant insertion, assemble the inner shaft and inserter handle, and then thread the appropriately sized implant onto the end.A mallet and slap hammer is provided to facilitate placement and removal.To protect the graft volume and ease the insertion of the interbody, graft containment ramps are available.One set has stops, in order to stop at the endplates and prevent the graft containment ramps from going onto the contralateral side.The root cause of the reported event can not be determined.Potential root causes include: off-axis loading of the implant during preparation could lead to the reported inner shaft thread damage.Proper trail sizes can be also used during preparation, to mitigate the higher forces / impaction requirement during implant insertion.
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 inserter inner shaft.

• Brand Name: LATERAL INSERTER INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11761183
• Report Number: 3004774118-2021-00134
• Device Sequence Number: 4366858
• Product Code: LXH
• UDI-Device Identifier: 10888857059252
• UDI-Public: 10888857059252
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150481
• 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 Model Number: 3201-90270
• Device Catalogue Number: 3201-90270
• Device Lot Number: GFRB
• 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