MAUDE Adverse Event Report: K2M, INC. MESA RAIL / ROD PULLER; MESA RAIL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	801-90143
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a mesa rail/rod puller was discovered to be bent pre-operatively.There was no patient involvement and therefore no adverse consequences were seen.
Event or Problem Description
It was reported that a mesa rail/rod puller was discovered to be bent pre-operatively.There was no patient involvement and therefore no adverse consequences were seen.
Additional Manufacturer Narrative
Visual, functional, and dimensional inspection were unable to be performed since the device was unavailable for evaluation.Material analysis was also unable to be performed.Review of the device history records could not be performed as a valid lot code was not identified.Review of the complaint history records could not be performed as a valid lot code was not identified.It was reported that a mesa rail/rod puller was bent and couldn't be used anymore.However, the issue was unable to be confirmed since the device was not available for evaluation.It is not clear what component of the device may have been affected or how the damage was sustained.Since the issue was reported to have been noticed after the operation, it appears that the damage was sustained during intraoperative use.It is possible that the rail puller was bent due to excessive force during the rotation maneuver.Ultimately, however, the alleged failure mode was unable to be properly evaluated, and no root cause for the issue was able to be determined.Hospital retained device.

• Brand Name: MESA RAIL / ROD PULLER; MESA RAIL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10341516
• Report Number: 3004774118-2020-00156
• Device Sequence Number: 3749123
• Product Code: LXH
• UDI-Device Identifier: 10888857143654
• UDI-Public: 10888857143654
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 801-90143
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1