MAUDE Adverse Event Report: K2M, INC. TORQUE INDICATING WRENCH; SIZE 25, MI; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	1001-90133
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the denali torque indicating wrench broke off intra-operatively.The procedure was completed sucessfully without surgical delay.No adverse consequences were reported.
Event or Problem Description
It was reported that the tip of the denali torque indicating wrench broke off intra-operatively.The procedure was completed sucessfully without surgical delay.No adverse consequences were reported.
Additional Manufacturer Narrative
A visual inspection was performed and it was observed that the male hexalobe feature at the distal tip was fractured and material wear was identified on the device.Complaint history record review was performed and no similar complaints were identified for the reported lot number and no adverse trends were observed from review of complaint history associated with the subject catalog number.Manufacturing records were not available for review.It was reported that the tip of the device fractured during final tightening of the set screw.Follow up revealed that the device was most likely not used past the indicated limits as it is unknown if complex maneuvers or excessive forces were applied to the device.The cause of the reported event cannot be determined conclusively.Based on the visual inspection and on the follow up information it is likely that the tip fractured due to normal wear however this cannot be determined conclusively.

• Brand Name: TORQUE INDICATING WRENCH; SIZE 25, MI
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 12884207
• Report Number: 3004774118-2021-00372
• Device Sequence Number: 5095375
• Product Code: LXH
• UDI-Device Identifier: 10888857001121
• UDI-Public: 10888857001121
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 03/09/2022

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 Catalogue Number: 1001-90133
• Device Lot Number: KUWM010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown