MAUDE Adverse Event Report: K2M, INC. DRILL; SIZE 2.3X14 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6808-90027
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
It was reported that a pyrenees segmental drill guide does not allow for the advertised purchase in a bone.This record captures the pyrenees segmental drill.
Event or Problem Description
It was reported that a pyrenees segmental drill guide does not allow for the advertised purchase in a bone.This record captures the pyrenees segmental drill.
Additional Manufacturer Narrative
It was reported that pyrenees 14mm segmental drill and drill guide only goes in 10mm.The procedure was completed successfully without surgical delay.No adverse consequences were reported.A minimum of 3 follow up attempts were performed to obtain additional information, but a response was not received.The reported device was not received so an evaluation could not be performed.Manufacturing records and complaint history could not be reviewed as the lot# was not provided.A review of complaint history for the associated catalog number was performed, and no complaints were identified.As the device was not returned and additional information was not received, an exact cause of the reported event could not be determined.Potential causes include: normal wear led to tip deformation of the drill, presence of foreign debris in the drill guide, etc.H3 other text: device not returned for evaluation.

• Brand Name: DRILL; SIZE 2.3X14 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11903578
• Report Number: 3004774118-2021-00157
• Device Sequence Number: 19720541
• Product Code: LXH
• UDI-Device Identifier: 10888857261754
• UDI-Public: 10888857261754
• Combination Product (Y/N): N
• 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): 09/30/2021

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 Model Number: 6808-90027
• Device Catalogue Number: 6808-90027
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1