MAUDE Adverse Event Report: OSTEOCENTRIC TECHNOLOGIES, INC. 4.0 X 38MM SCREW SUPER FASTENER, ST

Model Number	340-2038
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No specific root cause could be determined, all fasteners returned were built to specification, no nonconformances / manufacturing irregularities were identified during the manufacturing process.This complaint will be accounted for and monitored via post market surveillance activities.
Event or Problem Description
For a orif proximal humerus surgery, a combination of 4.0mm locking fasteners & 4.0mm fasteners were used in the head of the plate, while 3.5mm fasteners were implanted in the distal or shaft segment.Two locking prox hum fasteners backed out and one non locking fastener backed out.This report is 3 of 3 for (b)(4).
Additional Manufacturer Narrative
Udi releated data quality updates, product information update, initial reporter updates, & report source update: this follow-up report includes the addition of the brand name, model number, and full udi, which were missing from the initial report.The 510(k) was updated.The lot # and manufacturing date are on the device label, but are not on the label as a pi.This report specifies that this is not a combination product and that the product is for single use.Additionally, this report updates the initial reporter information to the physician who initially reported the issue and includes the report source of how the issue became known by osteocentric technologies, inc.

• Brand Name: 4.0 X 38MM SCREW SUPER FASTENER, ST
• Common Device Name: 4.0 X 38MM SCREW SUPER FASTENER, ST
• Manufacturer (Section D): OSTEOCENTRIC TECHNOLOGIES, INC.; 75 w 300 n; suite 150; logan UT 84321
• Manufacturer (Section G): OSTEOCENTRIC TECHNOLOGIES, INC.; 75 w 300 n; suite 150; logan UT 84321
• MDR Report Key: 18296872
• Report Number: 3011656326-2023-00014
• Device Sequence Number: 6970722
• Product Code: HWC
• UDI-Device Identifier: 00810074300131
• UDI-Public: (01)00810074300131
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K150981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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: 340-2038
• Device Catalogue Number: 340-2038
• Device Lot Number: DCW155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male