MAUDE Adverse Event Report: SKELETAL DYNAMICS SKELETAL DYNAMICS; HEADLESS COMPRESSION SCREW

Model Number	Screw, Headless Compression, 2.5mm x 10mm, Ti
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instructions for use provide that the user selects the type and size of implant to best meet the patient's needs.It also state that the device is not designed to withstand the stress of weight bearing, load bearing, or excessive physical activity, and that device breakage may occur when the device is subjected to excessive loading associated with delayed union or nonunion.
Event or Problem Description
Broken screw post-op.

• Brand Name: SKELETAL DYNAMICS
• Common Device Name: HEADLESS COMPRESSION SCREW
• Manufacturer (Section D): SKELETAL DYNAMICS; 7300 n. kendall drive; suite 400; miami FL 33156
• MDR Report Key: 11456582
• Report Number: 3006742481-2021-00002
• Device Sequence Number: 3105886
• Product Code: HWC
• UDI-Device Identifier: 00841506101835
• UDI-Public: 00841506101835
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

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: Screw, Headless Compression, 2.5mm x 10mm, Ti
• Device Catalogue Number: HCS-250XX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR