MAUDE Adverse Event Report: K2M, INC. AN LORDOTIC SPREADER; SIZE 28X8 MM, 12°; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5203-90167
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital retained device.
Event or Problem Description
Physician reported that a cascadia an lordotic trial; size 8.5x22x8mm 6° disengaged from the inserter and fractured while in the disc space intra-operatively.The trial was removed and surgery was successfully completed after a 65-minute delay.
Event or Problem Description
Physician reported that the tip of a cascadia an lordotic trial disengaged intraoperatively leading to a 65-minute extension of surgery.The tip was extracted from the disc space and the surgery was successfully completed with no adverse consequence to the patient.
Additional Manufacturer Narrative
The device was not returned for evaluation due to hospital limitations during covid-19 pandemic.Visual analysis of images of the device showed that the distal tip of the spreader was disengaged from the main body.Further investigation found the device to be non-conforming; although the spreaders require single-piece construction per their drawings, the supplier manufactured the instruments as two-pieces (tip and shaft), welded together.A product field action was initiated on 30 march 2020 and a letter with instructions pertaining to the removal and return of the product to stryker was sent to all affected consignees notifying them of the issue.Returned products will be scrapped.

• Brand Name: AN LORDOTIC SPREADER; SIZE 28X8 MM, 12°
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9842184
• Report Number: 3004774118-2020-00038
• Device Sequence Number: 14167147
• Product Code: LXH
• UDI-Device Identifier: 10888857108806
• UDI-Public: 10888857108806
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5203-90167
• Device Lot Number: FKXT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 004774118-4/9/2020-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention