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

Model Number	2112-90006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during implant placement a capri large expandable 'inserter tip broke' intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.The procedure was completed successfully.
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that the boss feature that mates with the capri implant was fractured.The broken tip component remains in the patient and was therefore not available for evaluation.Complaint history records were reviewed for this lot, and no similar complaints were identified.The capri large expandable surgical technique was reviewed and the following relevant information was identified: cage insertion: with the desired cage selected and assembled, pass the inserter threaded shaft down the inserter.Use the short size 20 non-tapered driver to thread the inserter onto the cage at the insertion point for the desired approach and introduce the cage into the site.If needed, use the curved or angled pusher to assist in positioning the cage.According to the rep, the disc space was tight and the patient had hard bone quality.Inserting the implant in a tight disc space, coupled with hard bone, likely surpassed the structural integrity of the instrument tip.
Event or Problem Description
It was reported that during implant placement a capri large expandable 'inserter tip broke' intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.The procedure was completed successfully.

• Brand Name: INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11809053
• Report Number: 3004774118-2021-00143
• Device Sequence Number: 3647010
• Product Code: LXH
• UDI-Device Identifier: 10888857033634
• UDI-Public: 10888857033634
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/07/2021

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: 2112-90006
• Device Catalogue Number: 2112-90006
• Device Lot Number: KHJV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR