MAUDE Adverse Event Report: K2M, INC. ANTI TORQUE HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	2112-90005
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was discovered that a capri large expandable anti torque handle "broke into 3 parts" after the procedure was completed successfully.There were no adverse consequences to the patient or surgical delay.
Additional Manufacturer Narrative
The device has been received and the lot number updated.
Event or Problem Description
It was discovered that a capri large expandable anti torque handle "broke into 3 parts" after the procedure was completed successfully.There were no adverse consequences to the patient or surgical delay.
Additional Manufacturer Narrative
The device was visually inspected, and it was observed that the weld mating the dowel pin to the wrench handle, lock key, and collar was broken, resulting in the disassembly of the instrument.The dowel pin and spring were not available for evaluation.Device and complaint history records were reviewed, no relevant manufacturing issues or similar complaints were identified.As the instrument was manufactured in 2017, repeated use over the lifetime of the instrument may have compromised the laser weld fixating these components.
Event or Problem Description
It was discovered that a capri large expandable anti torque handle "broke into 3 parts" after the procedure was completed successfully.There were no adverse consequences to the patient or surgical delay.

• Brand Name: ANTI TORQUE HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10701980
• Report Number: 3004774118-2020-00245
• Device Sequence Number: 14267572
• Product Code: LXH
• UDI-Device Identifier: 10888857033627
• UDI-Public: 10888857033627
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2020

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: 2112-90005
• Device Lot Number: GBML
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 11/30/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 11/04/2020; 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1