MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 7.5X50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-07550
Medical Device Problem Codes	Nonstandard Device (1420); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the shaft diameter of a mesa polyaxial screw was measured and found to be a different size than what was listed on the head of the screw.Review of product manufacturing history indicates this is an isolated incident.
Additional Manufacturer Narrative
Visual and dimensional inspection was performed and the screw measured at ø6.55 x 50 mm, compared to the laser marked diameter of ø7.5 x 50 mm. lot hhjr was released in a size of 85 units and inspected september 2018.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.  complaint history was reviewed and no similar complaints were identified for this lot.  the non-conformance and corrective preventive action investigation performed with the supplier has concluded that this is an isolated occurrence and that the discrepancy was limited to the one screw, described in this report.During the time period when the 7.5 x 50 mm screw lots were in inventory, 6.5 x 50 mm screws were received into inventory.Records show 1 piece from production lot of 6.5 x 50 mm screws was missing.It was concluded that the qc inspector was not using the gage in a "no-go" condition, which may have allowed a smaller shaft diameter to pass the gage.
Event or Problem Description
A company representative reported that the shaft diameter of a mesa polyaxial screw was measured and found to be a different size than what was listed on the head of the screw.

• Brand Name: POLYAXIAL SCREW; SIZE 7.5X50 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10378471
• Report Number: 3004774118-2020-00166
• Device Sequence Number: 16618532
• Product Code: NKB
• UDI-Device Identifier: 10888857136885
• UDI-Public: 10888857136885
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K141873
• 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): 10/27/2020

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: Lay User/Patient
• Device Model Number: 801-07550
• Device Catalogue Number: 801-07550
• Device Lot Number: HHJR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1