MAUDE Adverse Event Report: K2M, INC. TL INSERTER/IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6101-90164
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the distributor that the inner shaft was unable to be inserted into the handle as the there was a slight bend on the handle itself.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
Additional Manufacturer Narrative
Visual inspection: laser marking wear was throughout the main body.Functional inspection: deformation was noticed on the proximal end of the handle opening for the inner shaft.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It was reported that the instrument was functional before and during the surgery.The jamming issue was only observed after the cleaning/sterilization process.Proper cleaning and sterilization guidelines can be found in the cascadia tl surgical technique guide for reusable instruments.Since the issue was observed during the cleaning/sterilization process, the cause of the failure mode was determined to be user - customer error.
Event or Problem Description
It was reported by the distributor that the inner shaft was unable to be inserted into the handle as the there was a slight bend on the handle itself.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.

• Brand Name: TL INSERTER/IMPACTOR
• 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: 12562732
• Report Number: 3004774118-2021-00295
• Device Sequence Number: 1336806
• Product Code: LXH
• UDI-Device Identifier: 10888857283350
• UDI-Public: 10888857283350
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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: 6101-90164
• Device Catalogue Number: 6101-90164
• Device Lot Number: NBKV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 01/24/2022
• 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