MAUDE Adverse Event Report: K2M, INC. INNER THREADED FLEX SHAFT; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	4508-90143
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the threads of the inner shaft of a cayman mi flex shaft fractured intra-operatively.
Additional Manufacturer Narrative
B.5 was corrected form "it was reported that the threads of the inner shaft of a cayman mi flex shaft fractured intra-operatively." to "it was reported that the tip of the inner shaft of a cayman mi flex shaft fractured intra-operatively." d.4 was corrected from "lot efgy" to "efgy".Visual inspection: the device was inspected.It was observed that the distal tip fractured through the proximal end of the flexible.The laser-cut pattern was also deformed in the form of bending, indicating that the distal tip was likely overloaded in bending.Device and complaint history records were reviewed and no relevant manufacturing issues were identified.However, two similar complaints were identified.As the device was manufactured in 2016, the root cause of the reported event was determined to be normal wear and/or overloading of the device.Repeated use over the lifetime of the instrument may have compromised the material integrity of the threaded tip.
Event or Problem Description
It was reported that the tip of the inner shaft of a cayman mi flex shaft fractured intra-operatively.

• Brand Name: INNER THREADED FLEX SHAFT
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9788275
• Report Number: 3004774118-2020-00024
• Device Sequence Number: 1866614
• Product Code: LXH
• UDI-Device Identifier: 10888857095892
• UDI-Public: 10888857095892
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

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: 4508-90143
• Device Lot Number: EFGY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1