MAUDE Adverse Event Report: K2M, INC. TORQUE LIMITING HANDLE (1/4" SQUARE QUICK CONNECT); INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	201-90070
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a pyrenees torque limiting handle showed signs of wear and tear intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Event or Problem Description
It was reported that a pyrenees torque limiting handle showed signs of wear and tear intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Normal wear and tear was observed on the returned device.Device and complaint history records were reviewed for this lot and catalog number, no relevant manufacturing issues or adverse trends were identified.As the device was manufactured in 2013, repeated use of the device over the course of it's service life most likely led to this wear.

• Brand Name: TORQUE LIMITING HANDLE (1/4" SQUARE QUICK CONNECT)
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14706766
• Report Number: 3004774118-2022-00238
• Device Sequence Number: 19383687
• Product Code: MAX
• UDI-Device Identifier: 10888857029989
• UDI-Public: 10888857029989
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/12/2022

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: 201-90070
• Device Catalogue Number: 201-90070
• Device Lot Number: BUWD-018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female