MAUDE Adverse Event Report: K2M, INC. LORDOTIC AN INSERTER; SIZE 28 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	5203-90101
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the aleutian an lordotic inner inserter broke and was jammed into the aleutian an lordotic outer t-handle sheath intra-operatively.The procedure was completed successfully without surgical delay.
Event or Problem Description
It was reported that the aleutian an lordotic inner inserter broke and was jammed into the aleutian an lordotic outer t-handle sheath intra-operatively.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
The device was visually inspected.It was observed that the proximal threads of the inserter, which engages to the outer shaft internal threads, was fractured.Complaint history records were reviewed for this lot, no similar complaints were identified.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The instrument has been out in the field for more than 5 years.Factors such as consistent use of the instrument throughout its lifetime may cause fatigue on the instrument, leading to the observed fracture.The most likely root cause of the reported event was determined to be normal wear.Correction: further review of the risk documentation, device history, and the reported information regarding this event do not suggest a recurrence of this event would result in a serious injury.This event is no longer suggested to be reportable.

• Brand Name: LORDOTIC AN INSERTER; SIZE 28 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11266813
• Report Number: 3004774118-2021-00027
• Device Sequence Number: 4532727
• Product Code: LXH
• UDI-Device Identifier: 10888857108158
• UDI-Public: 10888857108158
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/25/2021

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: 5203-90101
• Device Lot Number: ELVV
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1